# K992630: Thermalight 2000

- Pathway: 510(k) (Traditional)
- Applicant: Jennifermaxx, Inc.
- Decided: Sep 10, 1999 after 87 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: 1 generation back to K895687 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895687: D'plume Xxii Photocoagulator (Epilation Machine), Carol Block, Ltd. (1990) Summary page 2.

## Indications for use
The THERMALIGHT 2000 is indicated for removal of unwanted body hair through the application of pulsed light energy applied to the hair follicle at the surface of the skin (non-invasive photo-epilation).

Source page: https://510kreport.com/device/K992630
Methodology: https://510kreport.com/methodology