# K030426: Omnilux Red

- Pathway: 510(k) (Traditional)
- Applicant: Photo Therapeutics Limited
- Decided: Jul 17, 2003 after 157 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: 8 generations back to K943450 (1995). 82 ancestors in all.
563 later devices descend from it; 19 cite it directly.
0 of 646 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) Summary page 1.
- K022266: Aurora SR, Syneron Medical, Ltd. (2002) Summary page 1.
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002) Summary page 1.

## Most influential descendants
- K042630: Revlight Skin Care System (2005), 402 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K081307: Omnilux Clear-U (2009), 169 descendants of its own
- K050216: Omnilux Revive and Omnilux Plus (2005), 160 descendants of its own

## Indications for use
The Revive is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.

Source page: https://510kreport.com/device/K030426
Methodology: https://510kreport.com/methodology