# K062991: Gentlewaves Consumer Led Photomodulation Device

- Pathway: 510(k) (Traditional)
- Applicant: Light Bioscience, LLC
- Decided: Feb 15, 2008 after 504 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- 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: 1 generation back to K031425 (2004). 1 ancestor in all.
22 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031425: Gentlewaves Led Photomodulation Device, Light Bioscience, LLC (2004) Summary page 1.

## Most influential descendants
- K092800: Anti-Wrinkle (Aging) Light, Model Aal (2010), 11 descendants of its own
- K150098: LightStim Professional 2-Panel Light (2015), 10 descendants of its own
- K090525: Loi System (2009), 9 descendants of its own
- K151333: LightStim for Pain LED Belt (2015), 4 descendants of its own
- K153399: LightStim Professional LED Bed (2016), 3 descendants of its own

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

Source page: https://510kreport.com/device/K062991
Methodology: https://510kreport.com/methodology