# K971874: Sharplan Epitouch Alexandrite Laser System (5000)

- Pathway: 510(k) (Traditional)
- Applicant: Sharplan Lasers, Inc.
- Decided: Aug 18, 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: 1 generation back to K963094 (1996). 1 ancestor in all.
816 later devices descend from it; 7 cite it directly.
0 of 818 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963094: Cynosure Photogenica LP Dermatological Vascular Lesion Laser, Cynosure, Inc. (1996) Summary page 1.

## Most influential descendants
- K981351: Candela Gentlelase GL Dermatological Laser (1998), 811 descendants of its own
- K991798: Acme Medical Aesthetic ND:Yag Laser (2000), 745 descendants of its own
- K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models (2002), 739 descendants of its own
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K022923: Candela Gentle Yag Laser System (2003), 656 descendants of its own

## Indications for use
The Sharplan Model 5000 Alexandrite Surgical Laser System is intended for use in dermatology for the treatment of vascular lesions.

Source page: https://510kreport.com/device/K971874
Methodology: https://510kreport.com/methodology