Manufacturer
Rohrer AestheticsUltraLight LED System
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K210535
- Device name
- UltraLight LED System
- Company
- Rohrer Aesthetics
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-02-24
- Decision date
- 2021-05-24
- Submission type
- Traditional
- Technology type
- LED(AI inferred)
- Clinical applications
- Body contouringVascular treatmentPigment treatmentAcne treatment
- Primary application
- Body contouring
- Classification source
- AI classified
Indications for Use
LED red light: The UltraLight "red light" is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The UltraLight "red light" is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions. LED blue light: The UltraLight "blue light" is indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. LED green light: The UltraLight "green light" is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
Intended Use
LED red light: The UltraLight "red light" is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The UltraLight "red light" is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions. LED blue light: The UltraLight "blue light" is indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. LED green light: The UltraLight "green Light" is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
Device Description
The UltraLight LED System is a low level laser system for aesthetic use. The device can emit three different wavelengths (i.e., red light @ 633 nm, blue light @ 415 nm, and green light @ 532 nm) to achieve its intended purpose. The device works by illuminating the skin with a single wavelength of red, blue, or green light. The device utilizes a 28.8cm X 38.0 cm irradiation board to deliver light directly to the desired target. The device is activated and controlled through the LCD control panel.
Summary parsed at:2026-06-01 05:42:45 UTC