# K210535: UltraLight LED System

- Pathway: 510(k) (Traditional)
- Applicant: Rohrer Aesthetics, LLC
- Decided: May 24, 2021 after 89 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K943450 (1995). 90 ancestors in all.
No later device cites it as a predicate yet.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180338: Cellulize, Ward Photonics, LLC (2018) Summary page 4.
- K160880: Photonica Professional, Ward Photonics, LLC (2016) Summary page 4.
- K030883: Omnilux Blue, Photo Therapeutics Limited (2003) Summary page 4.

## 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.

Source page: https://510kreport.com/device/K210535
Methodology: https://510kreport.com/methodology