# K030480: L600 Hair Removal

- Pathway: 510(k) (Traditional)
- Applicant: A&M Technology
- Decided: May 14, 2003 after 90 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: 6 generations back to K910422 (1992). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002)
- K020856: Spatouch Photoepilation System, Radiancy (Israel), Ltd. (2002)

## Most influential descendants
- K090724: OR-Light (2009), 0 descendants of its own

## Indications for use
The L600Q is a non-coherent light-based device designed for photothermal removal of unwanted hair of the face and the body in skin types I to IV through selective targeting of melanin in the hair follicle. The L600@ is intended to effect permanent hair reduction. According to the Food and Drug Administration, permanent hair reduction is defined as a long term and stable reduction in number of hair follicle re-growing after a treatment regime. The number of hair re-growing must be stable over time greater than the duration of a complete growth cycle of hair follicles according to body location.

Source page: https://510kreport.com/device/K030480
Methodology: https://510kreport.com/methodology