# K973354: Sharplan Epitouch Alexandrite Laser System (5000)

- Pathway: 510(k) (Traditional)
- Applicant: Sharplan Lasers, Inc.
- Decided: Dec 4, 1997 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: 2 generations back to K963094 (1996). 2 ancestors in all.
222 later devices descend from it; 7 cite it directly.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971874: Sharplan Epitouch Alexandrite Laser System (5000), Sharplan Lasers, Inc. (1997) Summary page 1.
- (no number) Cynosure Alexandrite Laser for Hair Removal: named in the summary without a submission number

## Most influential descendants
- K983977: Light Age Epicare Alexandrite Laser (1999), 118 descendants of its own
- K042474: ARION (2004), 114 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K984601: Candela Gentlelase II Dermatological Laser (1999), 110 descendants of its own

## Indications for use
The Sharplan Model 5000 Alexandrite Laser System is intended for use in dermatology for the removal of unwanted dark body hair.

Source page: https://510kreport.com/device/K973354
Methodology: https://510kreport.com/methodology