# K062312: Axiom Pulsed Light System

- Pathway: 510(k) (Traditional)
- Applicant: General Project S.R.L.
- Decided: Oct 16, 2006 after 69 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: 10 generations back to K910422 (1992). 74 ancestors in all.
No later device cites it as a predicate yet.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022583: FLASH 1, Emed, Inc. (2002) Summary page 1.
- K051508: Med Flash II Intense Pulsed Light System., General Project S.R.L. (2005)

## Indications for use
The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. It is intended for use in: Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction Treatment of mild to moderate inflammatory acne (acne vulgaris) Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and caf6-au-Iait.

Source page: https://510kreport.com/device/K062312
Methodology: https://510kreport.com/methodology