# K051255: Lumiphase-R

- Pathway: 510(k) (Traditional)
- Applicant: Opusmed, Inc.
- Decided: Jul 1, 2005 after 46 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). 84 ancestors in all.
143 later devices descend from it; 3 cite it directly.
0 of 228 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.
- K031425: Gentlewaves Led Photomodulation Device, Light Bioscience, LLC (2004) Summary page 2.

## Most influential descendants
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own

## Indications for use
The LumiPhase-R TM is indicated for treatment of wrinkles, rhytids and fine lines in the periorbital region.

Source page: https://510kreport.com/device/K051255
Methodology: https://510kreport.com/methodology