# K143666: Noblex Long Pulse Alexandrite Laser

- Pathway: 510(k) (Traditional)
- Applicant: Finemec Co., Ltd.
- Decided: Apr 23, 2015 after 121 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 K963094 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034030: Apogee Elite, Cynosure, Inc. (2004) Summary page 5.
- K024335: Candela Gentlelase Family of Laser Systems, Candela Corp. (2003) Summary page 5.

## Indications for use
The Noblex Long Pulse Alexandrite Laser is indicated for stable long-term or permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I -VI) including tanned skin. It is also indicated for the treatment of benign vascular lesions, benign pigmented lesions and wrinkles.

Source page: https://510kreport.com/device/K143666
Methodology: https://510kreport.com/methodology