# K131142: Genesis Led Wands

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Biosystems, Inc.
- Decided: Nov 27, 2013 after 218 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: 11 generations back to K943450 (1995). 130 ancestors in all.
No later device cites it as a predicate yet.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042630: Revlight Skin Care System, Skincare Technology, Inc. (2005) Summary page 1.
- K082586: Lightwave Professional Deluxe, Lightwave Technologies, LLC (2010) Summary page 2.

## Indications for use
Red 627nm Generally indicated for use in dermatology for treatment of superficial, benign vascular and pigmented lesions Blue 415nm Generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris

Source page: https://510kreport.com/device/K131142
Methodology: https://510kreport.com/methodology