# K200104: Oxylight

- Pathway: 510(k) (Traditional)
- Applicant: Raja Trading Company, Inc.
- Decided: Jun 4, 2020 after 139 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: 16 generations back to K943450 (1995). 237 ancestors in all.
24 later devices descend from it; 5 cite it directly.
0 of 262 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122237: Biophotas Lifelight, Biophotas, Inc. (2013) Summary page 4.
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 4.
- K090762: LEDA, Quantel Derma GmbH (2009) Summary page 4.

## Most influential descendants
- K240089: Face Patches (MT-12MA, MT-12MC) (2024), 16 descendants of its own
- K222751: LED Light Therapy Device, KN-7000L (2023), 11 descendants of its own
- K241293: LED Light Therapy Device, ELIXIR MD™ (2024), 7 descendants of its own
- K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (2024), 6 descendants of its own
- K242593: CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) (2025), 3 descendants of its own

## Indications for use
The Oxylight 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/K200104
Methodology: https://510kreport.com/methodology