# K202175: OxyLight 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Raja Trading Company, Inc.
- Decided: Dec 2, 2021 after 485 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: 17 generations back to K943450 (1995). 238 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200104: Oxylight, Raja Trading Company, Inc. (2020) Summary page 4.

## Most influential descendants
- K261673: LED Therapy Device (QLXY-01) (2026), 0 descendants of its own

## Indications for use
The Oxylight 2.0 is intended for dermatological use by physicians and healthcare professionals for the following: LED Technology is intended for: -Blue LED 465nm - to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. -Red LED 625nm- for treatment of superficial, benign vascular and pigmented lesions. -Yellow LED 590nm - treatment of periorbital wrinkles and rhytides. Microdermabrasion is intended for exfoliation of the skin. Oxygen spray is intended to refresh the skin.

Source page: https://510kreport.com/device/K202175
Methodology: https://510kreport.com/methodology