# K050216: Omnilux Revive and Omnilux Plus

- Pathway: 510(k) (Traditional)
- Applicant: Photo Therapeutics Limited
- Decided: Aug 9, 2005 after 190 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: 9 generations back to K943450 (1995). 89 ancestors in all.
160 later devices descend from it; 6 cite it directly.
0 of 250 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 2.
- K043317: Omnilux Plus, Photo Therapeutics Limited (2005). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K060792: Illumimed (2006), 115 descendants of its own
- K083183: Aklarus Phototherapy System (2009), 91 descendants of its own
- K072459: Omnilux New-U (2008), 91 descendants of its own
- K111286: Quasar Calypso (2012), 76 descendants of its own
- K162098: LED Phototherapy Device (2017), 75 descendants of its own

## Indications for use
The Omnilux Revive and Omnilux Plus Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Source page: https://510kreport.com/device/K050216
Methodology: https://510kreport.com/methodology