# K982316: Laseaway Alexandrite Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Silver Creek, Inc.
- Decided: Dec 16, 1998 after 167 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: 3 generations back to K963094 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973354: Sharplan Epitouch Alexandrite Laser System (5000), Sharplan Lasers, Inc. (1997) Summary page 1.
- K971874: Sharplan Epitouch Alexandrite Laser System (5000), Sharplan Lasers, Inc. (1997) Summary page 1.
- K961006: Medlite/755 Alexandrite Laser System, Continuum Biomedical, Inc. (1996) Summary page 1.
- K955662: Candela Q-Switched Alexandrite Lasers, Candela Laser Corp. (1996) Summary page 1.
- K940173: Candela Q-Switched Alexandrite Laser, Candela Laser Corp. (1994) Summary page 1.
- K944090: Candela Alex Lazr Q-Switched Alexandrite Laser, Candela Laser Corp. (1994) Summary page 1.

## Most influential descendants
- K990043: Smoothlase Alexandrite Laser System (1999), 0 descendants of its own

## Indications for use
The LaseAway Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The LaseAway 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/K982316
Methodology: https://510kreport.com/methodology