Part 1: Jett Plasma Medical Obtains FDA Clearance

Compex Jett Plasma enters the US market with a compact device that performs Plasmaporation, Tissue Tightening, and Tissue Heating. The first Triple Threat for Feminine Restoration.

This is HUGE! A generational change is upon us. Ten years ago radiofrequency and lasers stormed the stage and became the standard for Feminine Wellness and non-surgical “Vaginal Rejuvenation.” After 7 years of an intense approval process, on January 21, 2025, Compex of the Czech Republic, and their Jett Plasma Medical device, received their FDA 510k clearance in the United States. Let me explain why this is so important for the field of Cosmetic Gynecology.

  1. Plasma technology: DC current (Direct Current) in the 1-5 milliampere range is able to create non-ablative plasma energy at the Silver tips. This stimulates comfortable heat up to 42 Celsius, stimulates fibroblasts and tightens skin, results in increased blood flow and moisture, collagen formation, elastin formation, and nerve sensitivity improvement.

  2. Plasma technology: DC current creates plasma energy at the Gold tips for ablation and shrinkage of lesions and skin. Treats HVP/Warts/Molluscum/Angiomas.

  3. Plasma technology: DC current opens up the cell membrane’s water channels and allows for the temporary passage of macro and micro molecules deep into the cell in a process called electroporation.

    1. Infuse PRP, PPP, Exosomes, Amniotic Fluid, topical steroids: to revitalize skin and reduce inflammation (lichen, dermatitis, eczema, psoriasis). Reduce inflammation of skin and give skin a vibrant glow.

    2. Infuse Vitamin A or C or Hydroquinone or Kojic Acid: Vulvar lightening treatments

    3. Infuse Collagen Type 1: Plump up skin and reduce wrinkles. Reduce inflammation of skin and give skin a vibrant glow.

  4. Reusable hand pieces with no disposables. Additional dedicated gynecologic wands arriving in the US market soon.

  5. Affordable Lower Cost: About 1/3rd to 1/4th the price of competing systems allowing this technology to be the CORE device of both cosmetic and functional gynecology.

  6. Synergy: One device for Plasmaporation and Feminine Restoration (equivalent to Radiofrequency results) that is effective and cleared for use on the face and body.

Below are the brochures and advertisements used for the European and World markets as well as the FDA Clearance and the Vaginal Laxity study used to gain US approval. Enjoy this Part 1 video. Part 2 will be released later this week and shows how I use Plasmaporation to numb labial and vaginal tissues (before labiaplasty and vaginoplasty), as well as for vulvar lightening.

For more information contact Distributor: Dan Wray: danwray64@icloud.com

Red Alinsod, MD (red@gynflix.com)

WHAT IS JETT PLASMA: European/Worldwide indications

A patented direct current electrocautery device indicated for non-ablative treatment of vulvovaginal laxity causing tissue tightening and strengthening. Unique direct current technology provides a solution for issues connected to vulvovaginal laxity, such as insufficient vaginal moisture, burning and itching, stress incontinence and sexual discomfort due to vaginal dryness, reduced tightness, elasticity and sensitivity. Developed mainly for women after childbirth and menopause.

MECHANISM

The positive effect of JETT PLASMA For Her II is caused by combination of heat, membrane depolarization and low threshold reversible electroporation. The passage of direct current generates heat, which activates the formation of new collagen connective tissue, leading to a rejuvenation and stronger and more flexible tissue structure. In addition to the heat effect, unique direct current technology causes membrane depolarization and reversible electroporation which reduces the barrier and enable easier passage of ions and molecules through cell membranes.

The procedure is painless, well tolerated and it does not require local anaesthetic application. It solves rejuvenation of atrophied vaginal mucosa. It is suitable also in cases when local estrogen vaginal creams cannot be applied (condition after oncological diseases) with estrogen-dependent tumours.

VULVOVAGINAL TREATMENT PRINCIPLE

Small micro-discharges occur in the gel between the applicator and the tissue. Micro-discharges cause local increase of electric intensity. When this intensity reaches certain threshold value, the electroporation appears. Micro-discharges randomly arise and disappear in huge numbers, which ensures desired effect in the treated area.

Local increase of electric intensity causes nanopore formation in the cell membrane. Macromolecules and ions can easily get into the cell through these pores.

- The cells are refreshed and increase its volume.

- The atrophy of vaginal mucosal and submucosal tissue decrease.

- The cohesion between mucosal and submucosal tissue is improved.

After treatment using Jet Plasma, patients reported significant improvement in her sexual quality of life with reduction of incontinence, urgency, and atrophy.

INDICATIONS IN EUROPE

•Incontinence (SUI, OAB)

•Rejuvenation and skin tightening

•Atrophy and dryness of skin

•Labial shrinkage

•Pain and Discomfort from GSM (lack of elasticity and skin thickness)

ADVANTAGES

•Safe, comfortable, painless

•Short treatment time

•Non–surgical

•No need for anesthesia

•No hormones

•No scars

•3 treatments with an interval of 10-14 days (complete series in 6 weeks)

MARKETING BROCHURES FOR EUROPE AND WORLDWIDE

Jett Plasma technology has been well received in the plastic surgery, dermatology, and ophthalmology specialties for its ability to vaporize lesions with milliampere energy, for its ability to shrink tissues both in an ablative and non-ablative manner. Now they enter the field to help improve Feminine Wellness.

Jett Plasma For Her Ii En 2020
5.31MB ∙ PDF file
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Jett Plasma Europe
3.93MB ∙ PDF file
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K240311

Trade/Device Name: JETT Medical II

Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories

Regulatory Class: Class II

Product Code: GEI

Dated: December 13, 2024

Received: December 13, 2024

Treatment of Vulvovaginal Laxity by Electroporation: The Jett Plasma Medical for Her II Study

Jett Plasma Medical For Her Ii Study Vulvovaginal Laxity
1.02MB ∙ PDF file
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PROTOCOL FOR JETT PLASMA

We are in the middle of clinical studies at the Alinsod Institute in Dallas, Texas, on the safe use of Jett Plasma technology and its clinical applications. We are the Jett Plasma Center of Excellence and Training Center for this transformative device. My first talks on Jett Plasma will be at the Annual ISCG Congress in Fort Lauderdale, Florida, in March 2025.

Pre-Congress Sign Ups are Open for the Annual ISCG Congress 2025!

If you have not been to an ISCG Congress then you must attend ISCG 2025. Plan ahead for for March 20-22, 2025 in Fort Lauderdale. Lots of amazing topics and world leaders to present them. Meet and speak with the BEST.

HIGHLIGHTS for ISCG 2025
Cutting Edge Cosmetic Gyn Program
Expert Body Contouring Sessions
Expert Marketing & Business Sessions
​The Dr. Miami Experience
Spanish Session

SPECIAL EVENTS
The President's VIP Dinner
ISCG Awards Ceremony

Here are some examples of Dr. Pelosi’s presentations at past ISCG Congress:

  1. Cosmetic Gyn State of the Art 2017

  2. Cosmetic Gyn State of the Art 2018

  3. Cosmetic Gyn State of the Art 2019

  4. Cosmetic Gyn State of the Art 2020

  5. Cosmetic Gyn State of the Art 2021

  6. Cosmetic Gyn State of the Art 2022

  7. Cosmetic Gyn State of the Art 2024

GYNFLIX COMMUNITY HAS LAUNCHED!

On January 2025 I will launch Gynflix Community on X (formerly Twitter). This is my second announcement. Go join it. I will build an online community of expert Cosmetic Gynecologists from around the world who you will be able to communicate with and pick their brains. Click on the logo picture for the link:

GYNFLIX Cosmetic Gynecology e-Learning

For Detailed Videos Click on the Index Photo Below:

Go to this Index of my Surgeries on www.gynflix.com and view several hundred detailed 4k cases. You will learn a ton.

For more Cosmetic Gynecology Training join Gynflix.com

Gynflix is an online e-Learning platform dedicated to Feminine Wellness. Videos of topics such as labiaplasty, vaginoplasty, cliteroplasty, clitoral hood reduction, anal skin tag excision.

Click here for Silver Bullet Subscription at $98 a month: Gynflix Subscription

Contact Suzette Peterson at ‭(909) 374-1000‬ or email her at sette.peterson@gmail.com if you are interested in Fellows Gold Subscription at $198 a month.

GOLD FELLOWS MEMBERSHIP: This unique and valuable service provides access to all future surgical and non-surgical videos on www.gynflix.com. There will be 1-2 complete and unique videos per month. Dr. Alinsod will be available to discuss the intricacies and details of topics covered in the videos and answer specific questions that may arise . This is the first and only true Master’s Course for continuing education focused on cosmetic gynecology.

I love hearing from my Fellows, Grads, subscribers. Text or email me. I answer questions from all around the world!

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DALLAS OFFICE
Alinsod Institute Dallas
Women’s Wellness Institute of Dallas
Preston Sherry Plaza
8201 Preston Road Suite 520
Dallas TX 75225
Phone: 945-900-7576
Contact:
Dr. Red Alinsod: red@gynflix.com

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