After more than a decade of extensive R & D combined with a multi-million dollar investment, LightStim of Irvine, CA has been granted the very first over-the-counter (OTC) FDA 510K Clearance for its LED (light-emitting diode) light devices with LightStim patented MultiWave® technology for the treatment of full-face wrinkles.
Game-Changing Opportunity for All Salons
According to LightStim CEO, Steve Marchese, “Originally, LED devices were only FDA-cleared for treatment of periorbital [around the eye] wrinkles, or by prescription and for use by medical professionals. The FDA OTC clearance of LightStim for the treatment of wrinkles on the entire face allows the owners of salons, spas, etc., to add this proven anti-aging, wrinkle-reducing system to their businesses. And, they can legally market the systems using specific medical claims related to the device.”
Light Therapy to Reduce Wrinkles
The LightStim Professional 2-Panel System for Wrinkles contains 1,130 LED lights.
The MultiWave® LED technology emits four therapeutic light wavelengths:
- 605nm Amber
- 630nm Red
- 660nm Red
- 855nm Infrared
Joniann Marchese – Steve’s wife and LightStim President – explains, “The amber and red wavelengths help build collagen, elastin and other proteins in the skin. The Infrared wavelengths help accelerate healing, reduce inflammation and promote circulation.
“The skin cells absorb the therapeutic light and use it as a source of energy to stimulate cellular function. The combination of the four therapeutic wavelengths within close proximity to the skin contributes to the overall effectiveness and results of the LightStim system – and it’s part of the reason why more than 18,000 spas and estheticians use LightStim LED devices for their clients,” she adds.
FDA Requires Scientific Evidence to Prove Lasting Results
For LightStim to receive the 510K Clearance, three doctors were required to perform extensive, controlled and documented clinical studies on more than 80 patient-subjects during an eight-week period. The subjects represented a cross-section of men and women of all ages, with all skin types, ethnic backgrounds, lifestyles and occupations.
“The FDA also required proof that the LightStim devices were able to deliver lasting results. To verify this, patient-subjects were required to come back three months after the eight-week clinical study was completed to be measured and re-analyzed by the doctors who were in charge of the study,” says Steve.
“At the end of the study, the doctors found that 100% of the subjects showed a ‘significant improvement in their fine lines and wrinkles,’” states Joniann.
“Even more amazing is the fact that three months after the study ended, 100% of the participants were found to have held the improvements in their wrinkles that were attained during the clinical study and approximately 92% actually showed further improvement in their fine lines and wrinkles,” she adds.
These independently authenticated and verified results were then cataloged and sent to the FDA for review and 510K Clearance.
Benefits All Skin Types
LightStim works on men and woman of all skin types and ethnic backgrounds. The typical session time is 20 minutes, and the device may be used stand-alone while customers relax in a comfortable reclining chair, or used in conjunction with other beauty and massage treatments.
Completely portable, LightStim can easily be moved from room-to-room as needed or showcased in the salon’s lobby area – depending upon customer and salon preferences.
The LightStim unit features a built-in timer and offers hands-free, attendant-free operation. This presents a tremendous labor and cost savings advantage. LightStim does not emit any UV light and there is no risk associated with overexposure.
Immediate Results Include:
- Minimizes appearance of pores, fine lines and wrinkles (temporary plumping effect)
- Increases blood circulationand oxygenation
- Reduces inflammation/Accelerates healing
- Tones the skin/Produces a radiant glow
- Promotes better product absorption (thermal affects)
- Visibly improves the results of other services (layering)
Cumulative Results Include:
- Reduces and eliminates fine lines and wrinkles
- Repairs and rebuilds collagen, elastin and other proteins/enzymes
- Improves cellular function
Affordable Investment
Priced under $5,000 and with attractive financing options available, savvy business owners will quickly calculate that selling just a few packages each month will easily cover the monthly payment and provide a substantial return-on-investment.
“The LEDs have a 100,000 hour life, and there are virtually no parts to replace or maintain,” says Steve. “The cost per session to operate is pennies! It’s the perfect addition to any salon, spa, massage center, health & wellness area or weight-loss center,” he adds.
Exclusive Skin Care Formulations and Portable LED Lights
The effects of the LightStim can be further enhanced when used in conjunction with the company’s proprietary Light Activated Skin Care with Photosome-based formulations including LightStim PhotoSerum and LightStim PhotoMasque.
To help maintain the beneficial effects of the commercial system, LightStim also offers hand-held Lights that can be sold in-salon to customers for home use.
“Salons can generate additional income by selling our exclusive line of skin care products together with the portable, hand-held Lights, which can be used at home or when traveling,” states Joniann.
There are three Light types available and all have FDA 510K / OTC Clearance:
- Anti-Aging
- Acne Treatment
- Pain Relief
A Family Centered, American Manufacturer LightStim, the No.1 LED Light used by skin care professionals, is privately held by husband-and-wife duo, Steve and Joniann Marchese. The company proudly designs, engineers and manufactures all LightStim devices inside their ISO-certified facility in Irvine, CA, ensuring the paramount quality of the LightStim range.
Married and in business together for over 25 years, Steve and Joniann reside in sunny Newport Beach, CA. Working with them at LightStim is son Chase, Vice President of Manufacturing; son Addison, Creative Director; and Addison’s wife Michele, Designer.
Exclusive Representation
Greg Nehrlich, a 25-year tanning industry veteran, is the exclusive LightStim Manufacturer’s Representative for the tanning industry. He can be reached at 619.610.8600, by email at greg@sunspapro.com or visit sunspapro.com for more information.
