# K043329: Omnilux Revive and Blue

- Pathway: 510(k) (Traditional)
- Applicant: Photo Therapeutics Limited
- Decided: Mar 18, 2005 after 106 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). 83 ancestors in all.
202 later devices descend from it; 3 cite it directly.
0 of 286 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.
- K013623: Clearlight Phototheraphy System, Model CL 420, Curelight, Ltd. (2002) Summary page 2.

## Most influential descendants
- K081307: Omnilux Clear-U (2009), 169 descendants of its own
- K121435: Silkn Blue (2013), 125 descendants of its own
- K123999: Illumask Acne Light Therapy Mask (2013), 112 descendants of its own
- K140471: Pro X Otc 5 (2015), 107 descendants of its own
- K163329: Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 (2017), 106 descendants of its own

## Indications for use
The Omnilux Revive and Blue Combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

Source page: https://510kreport.com/device/K043329
Methodology: https://510kreport.com/methodology