# K990043: Smoothlase Alexandrite Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Leisegang Medical, Inc.
- Decided: Feb 11, 1999 after 36 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: 4 generations back to K963094 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971737: Cynosure Photogenica Lpir Dermatological Laser, Cynosure, Inc. (1997) Summary page 1.
- K982316: Laseaway Alexandrite Laser System, Silver Creek, Inc. (1998) Summary page 1.

## Indications for use
The SmoothLASE Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The SmoothLASE Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.

Source page: https://510kreport.com/device/K990043
Methodology: https://510kreport.com/methodology