Vaginal Rejuvenation

Vaginal laser Rejuvenation is an energy based treatment that can be a potential non-hormonal solution for problems many women experience.

208-367-0700

betterskin@spa35.com

For years women have suffered silently from intimate health issues. They have suffered from the effects of child birth, the aging process (including menopause) and chemotherapy with few options. Until recently the only options were invasive surgical procedures that required cutting, sutures, anesthesia and long down times.

Now women have the option of a non-surgical procedure that may help with their intimate health common concerns with minimal downtown and little discomfort.

The CO2RE Intima® is an in-office, non-surgical treatment that uses laser energy to help women with changes in vaginal health.

The CO2RE Intima® is a medical laser that delivers controlled energy to the vaginal or vulva tissue - so cells make more collagen - improving skin tone, texture and appearance. The delivery of this laser energy to the vaginal wall stimulates a healing response that results in remodeling of the tissue fibers, thereby restoring flexibility and shape. It uses the same type of energy that has been used to treat signs of aging in the face, loose and discolored skin - it is a CO2 energy based service.

Feminine Rejuvenation is an off label use of the laser device that has been approved for gynecologic indications. The FDA has NOT reviewed this service for efficacy in vaginal rejuvenation or to support any claims of improvement in incontinence, symptoms of menopause or intimacy enhancements. Recently the CO2RE was approved for genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI) in Canada. No approvals have been received in the U.S.

How Does Laser Rejuvenation Work?

The CO2RE Intima ® is a laser device designed to rejuvenate the tissues of the interior and exterior of the vagina to return it to a more youthful structure and appearance. This is a quick non-surgical procedure with minimum downtime and almost no discomfort. Laser energy is used to rebuild and refresh the cells of the vagina, restoring youthful function, comfort and appearance.

A thin, single use hygienic hand piece is placed into the vagina. Then a series of short beams of light are directed toward the vaginal wall and rotated until a 360 degree treatment path has been achieved. The hand piece is re-positioned for the next treatment depth and the process is repeated until the entire vaginal canal has been treated.

Three treatments are performed for maximum results. Touch up treatments may be desired after the initial three.

Next the external treatment hand piece is utilized to resurface the labia and other vulvar structures.

New collagen, and other dermal structures rebuild and increase as a result of the laser treatment. Returning tissue to a more youthful state.

Why Chose Spa 35® Med Spa for Your feminine Rejuvenation Treatments?

Please note, the FDA issued a warning letter to the manufacturers of energy based devices that were marketed for vaginal rejuvenation, you can view a summary of the letter by clicking on this text. While the laser utilized in feminine rejuvenation has been studied as a treatment for gynecologic disease conditions, it has not been studied for vaginal rejuvenation.

The medical providers at Spa 35 Med Spa have been delivering cosmetic services for more than thirteen years. Our staff includes Nurse Practitioners, Registered Nurses and Aestheticians.

• Experience - Spa 35® Med Spa has been helping clients Look and Feel their Best for twelve years.

• Cleanliness and Sanitation - Spa 35 selected a vaginal rejuvenation device that uses disposable hand pieces to give you peace of mind about the quality of your treatment.

• Customized Laser Skin Rejuvenation Rooms - You get the most comfortable treatment possible, with an individual cooling system and externally exhausted air system in your treatment room. Vaginal Rejuvenation treatments can feel hot, so we designed our laser rooms with dedicated air conditioners to deliver cool air while fans pull out the hot air from each room, so you have the best experience possible.

• Medical Staff - The team is led by Nurse Practitioners and composed of Registered Nurses and aesthetic skin care professionals.

• Industry Leadership - Warren Danforth, the Spa 35® owner, is a Key Opinion Leader for Candela's Medical Spa Program. Candela is a global non-surgical aesthetic device company and the maker of Profound®, Intima® and CO2RE®.

• Broad Scope of Expertise - From Botox to CoolSculpting Fat Reduction and Vaginal Rejuvenation, Spa 35® Med Spa has an extensive set of experience to help you reach your goals. This means you get the expertise to help you select the service(s) are right for you and your budget.

• Continuum of Cosmetic Services - A Cosmetic Surgeon is in the same building as Spa 35. If your goals are best met through procedures than those offered in our Med Spa we can refer you to a surgeon. Looking for a facial or massage? We can also suggest great providers for those services.

• Customer Reviews - Spa 35 has the most Google five star reviews among Med Spas in Boise. We also have great reviews on Facebook and YELP.

Vaginal Wellness Frequently Asked Questions

QUESTION: How Long Does It Take?
ANSWER: The procedure is completed in about 20 minutes. The total time of your appointment will be about an hour. This includes time to complete and review paperwork, pre-care and post-care instructions and topical numbing.

QUESTION: Is One Treatment Enough?
ANSWER: Three treatments are recommended for maximum results. The treatments are spaced 4-8 weeks apart. For best ongoing results we recommend a yearly “touch-up” treatment (a single procedure).

QUESTION: When Will I "See" Results?
ANSWER: Within four weeks of the procedure most women begin to feel internal changes. The external area will show results in 10-15 days

QUESTION: How Much Downtime Will I Have?
ANSWER: From a daily routine perspective there is no downtime from the procedure. You can got back to work or your household activities immediately after the procedure. Nothing should be placed in the vagina for 5-7 days after the procedure (tampons, etc.). See the informed consent paperwork for more details.

Question: How Much Does Vaginal Laser Rejuvenation Cost?

Answer: A series of an initial three treatments is typically $2,999. A single treatment annual touch-ups are recommended.

QUESTION: What is the Difference Between this procedure and Laser Vaginal Rejuvenation ® (LVR ®)?
ANSWER: Laser Vaginal Rejuvenation ® and LVR ® are registered trademarks of Dr. David Matlock. It is a more aggressive procedure that uses a combination of light based surgical and non-surgical methods to resize the vaginal canal and labia. You can find more on Dr. Matlock’s procedure here - http://www.drmatlock.com/body-procedures-beverly-hills/laser-vaginal-rejuvenation-lvr/ .

QUESTION: What is the Difference this procedure and Labiaplasty?
ANSWER: Labiaplasty is a surgical procedure to reduce the size of the labia. It can be combined with other surgical and non-surgical treatments to help patients achieve their aesthetic goals. More information can be found here:  https://en.wikipedia.org/wiki/Labiaplasty .

QUESTION: Does This Procedure Require Me To Be Sedated Or Under General Anesthesia?
ANSWER: No. The procedure is relatively pain free. A topical analgesic is applied to the external treatment area. The internal treatment does not require any numbing.

QUESTION: What Type of Equipment Is Used In This Procedure?
ANSWER: The Intima Procedure is performed with the CO2RE Intima CO2 Laser manufactured by Candela.

QUESTION: Is Vaginal Rejuvenation FDA approved?

ANSWER: The laser used for Vaginal Rejuvenation has been reviewed by the FDA for the treatment of gynecological issues, particularly for the ablation of unwanted tissues using the CO2 energy. But there is NOT a clearance for for the broader term of Vaginal Rejuvenation. There are no clinical studies to support any claims of improvements in incontinence or intimacy via the laser in use by Spa 35. Spa 35 vaginal treatments are off label uses of a device that has been reviewed for other gynecologic issues, but not vaginal rejuvenation, by the FDA.

The Aesthetic Guide published a great article on vaginal health achieved with the CORE Intima, the device Spa 35® uses to help women maximize their intimate wellness. 

Here are some notable quotes from the article-

Dr. Samuels - "CO2RE Intima is a great tool for women's wellness. With external treatment you can also deal with dyschromia, but the internal treatment conveys a powerful medical benefit that affects a woman's quality of life"

Dr. Shafer- "Intima provides a non-surgical procedure for patients who either don't require surgery, prefer a non-surgical approach or are better candidates for laser treatment. The actual treatment is quick, painless and effective so our return rate for a second session has been 100%."

Dr. Garcia- "The depth of penetration and ratio of ablation to coagulation of the fractional CO2 laser are essential to the remodeling of tissue in the vaginal area. RF treatments do not ...."

Dr. Patel- "I have some patients as young as their early 20s wanting better 'tightness", women in their 20s or 30s wanting to treat post-partum vaginal looseness, and older women with functional problems stemming from menopause.

Are you ready to love every part of you? The sooner you set up your consultation, the sooner you'll see results. Contact us today to find out if Non-Surgical Vaginal Rejuvenation is right for you.

208-367-0700

FDA

Study on Fractional CO2 laser treatment for vulvovaginal atrophy symptoms and vaginal rejuvenation in perimenopausal women

MonaLisa Touch study on vaginal atrophy treatment

The Intima Vaginal Wellness treatment is performed with the CO2RE carbon dioxide laser device. The device has regulatory clearance for a long list of medical and cosmetic conditions. There is NOT a clearance for Vaginal Rejuvenation. This treatment is an off label use of the device. Below is language from the CO2RE System 510 K, the complete document can be found at https://www.accessdata.fda.gov/cdrh_docs/pdf15/K151655.pdf

Vaginal Rejuvenation is not an FDA cleared procedure, it is an off label use of the device. 

510 K Language;

Indications for Use (Describe) The CO2RE is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy(knee). The CO2RE is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.

The Standard Handpiece of the CO2RE System is indicated for the following: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: laser skin resurfacing, laser dermabrasion, laser burn debridement. Laser skin resurfacing (ablation and/or vaporization)for the treatment of: wrinkles, rhytids, and furrows (including fines lines and texture irregularities) Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic wart, and verruca seborrheica; vermillionectomy of the lip; cutaneous horns; solar/actinic elastosis; chelitis, including actinic chelitis; lentigines, including lentigo maligna or Hutchinson's malignant freckle uneven pigmentation/ dyschromia; acne scars; surgical scars; keloids including acne keloidalis nuchae; hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum); tattoos; telangiectasia; removal of small skin tumors, including periungual (Koenen) and subungual fibromas; superficial pigmented lesions; adenosebaceous hypertrophyor sebaceous hyperplasia; rhinophyma reduction; cutaneous papilloma (skintags); milia; debridement of eczematous or infected skin; basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis(BP) lesions; nevi, including spider, epidermal and protruding; neurofibromas; laser de-epithelialization; tricoepitheliomas; anthelasma palpebrarum; syringoma Laser ablation, vaporization and /or excision for complete or partial nail matrix ectomy. Vaporization/coagulation of: benign/malignant vascular/avascular skin lesions; Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts.

Podiatry Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of: verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts; fungal nail treatment; porokeratoma ablation; ingrown nail treatment; neuromas/fibromas, including Morton's neuroma; debridement of ulcers; other soft tissue lesions. Laser ablation, vaporization and /or excision in podiatry for complete or partial matrix ectomy.

Otolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of: leukoplakia, including oral, larynx, uvula, palatal, upper latera pharyngeal tissue; nasal obstruction; adult and juvenile papillomatosis polyps; polypectomy of nose and nasal passages; lymphangioma removal; removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords; superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease; rhinophyma; verrucae vulgares (warts);

Gynecology(GYN) Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions; leukoplakia (vulvardystrophies); herpes vaporization; urethralcaruncl evaporization; cervical dysplasia; benign and malignanttumors;

Dental/Oral Surgery Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: treatment of ulcerous lesions, including aphthous ulcers; excision and ablation of benign and malignant lesions; leukoplakia;

Genitourinary Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include: benign and malignant lesions of external genitalia; condyloma; erythroplasia

The Fractional Handpiece of the CO2RE System is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.

The Surgical Handpiece of the CO2RE System is indicated for the following: Dermatology& Plastic Surgery Laser skin resurfacing (ablation and/or vaporization)of soft tissue for the reduction, removal, and/or treatment of: vermillionectomy of the lip; cutaneous horns; removal of small skin tumors, including periungual (Koenen) and subungual fibromas; rhinophyma reduction; basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; neurofibromas; Laser ablation, vaporization and /or excision for complete or partial nail matrix ectomy. Vaporization/coagulation of: benign/malignant vascular/avascular skin lesions; Moh'sSurgery; Lipectomy; Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

Podiatry Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of: verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts; Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.

Otolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngologythe treatment of: choanal atresia, nasal obstruction; adult and juvenile papillo matosis polyps; polypectomy of nose and nasal passages; lymph angioma removal; removal of vocal cord/fold nodules,polyps and cysts; removal of recurrent papillomas in the oral cavity, nasal cavity,larynx,pharynx and trachea,including the uvula,palatal,upper latera lpharyngeal tissue,tongue and vocal cords; laser/tumor surgery in the larynx,pharynx,nasal,ear and oral structures and tissue; Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophago divertuculostomy (ELAED)]; stenosis, including subglottic stenosis; tonsillectomy(including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy; pulmonarybronchial and tracheal lesion removal; benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial); benign and malignant lesions and fibromas (nose and nasal passages); benign and malignant tumors and fibromas (oral); stapedotomy/stapedectomy; acoustic neuromain the ear; superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease; telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue); cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea; myringotomy/tympanostomy(tympanic membrane fenestration); uvulopalatoplasty (LAUP, laserUPPP); turbinectomy and turbinate reduction/ablation; septal spur ablation/reduction and septoplasty; partial glossectomy; tumor resection on oral, subfacial and neck tissues; rhinophyma; verrucae vulgares (warts); gingivoplasty/gingivoctomy.

Gynecology(GYN) Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions; incision and drainage (l&D) of Bartholin's and nubuthiancysts; benign and malignant tumors; hemangiomas.

GYN Laparoscopy Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of: endometriallesions, including ablation of endometriosis; excision/lysisofadhesions; salpingostomy oophorectomy/ovariectomy; fimbrioplasty; metroplasty; microsurgery(tubal); uterine myomas and fibroids; xovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy.

Neurosurgery Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of: Cranial posterior fossa tumors; peripheral neurectomy; benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including basal tumors), acoustic neuromas, lipomas and large tumors); arteriovenous malformation; pituitary gland tumors (transphenoidal approach). Spinal Cord incision/excision and vaporization of benign and malignant tumors and cysts; intra- and extradural lesions; laminectomy/ laminotomy/ microdiscectomy.

Orthopedics Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include: Arthroscopy menisectomy; chondromalacia; chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy.

General debridement of traumatic wounds; debridement of decubitus and diabetic ulcers; microsurgery; artificial joint revision; PMMA removal.

General/Thoracic Surgery Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include: debridement of decubitus ulcers, stasis, diabetic and other ulcers; mastectomy; debridement of bums; rectal and anal hemorrhoidectomy; breast biopsy; reduction mammoplasty; cytoreduction for metastatic disease; laparotomy and laparoscopic applications; mediastinal and thoracic lesions and abnormalities; skin tag vaporization; atheroma; cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; pilonidal cyst removal and repair; abscesses; other soft tissue applications.

Dental/Oral Surgery Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: xgingivectomy- removal of hyperplasias; xgingivoplasty; xincisional and excisional biopsy; xincision of infection whenused with antibiotic therapy; xfrenectomy(frenum release); xexcision and ablation of benign and malignant lesions; xhomeostasis; xoperculectomy; xcrown lengthening; xremoval of soft tissue, cysts and tumors; xoral cavity tumors and hemangiomas; xabscesses; xextraction site hemostasis; xsalivary gland pathologies; xpreprosthetic gum preparation; xpartial glossectomy; xperiodontal gum resection.

Genitourinary Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include: benign and malignant lesions of external genitalia; condyloma; Phimosis; Erythroplasia.