# K031425: Gentlewaves Led Photomodulation Device

- Pathway: 510(k) (Traditional)
- Applicant: Light Bioscience, LLC
- Decided: Dec 15, 2004 after 590 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
No predicates in its family tree.
199 later devices descend from it; 6 cite it directly.
0 of 200 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051255: Lumiphase-R (2005), 143 descendants of its own
- 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

## Indications for use
The GentleWaves LED Photomodulation Device is indicated/intended for use in the treatment of periorbital wrinkles and rhytides.

Source page: https://510kreport.com/device/K031425
Methodology: https://510kreport.com/methodology