# K980710: Schwartz Electro-Optics, Inc. Crystalase 755 DP Alexandrite Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Schwartz Electro-Optics, Inc.
- Decided: May 22, 1998 after 87 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 K950831 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K950831: Alexlazr, Candela Laser Corp. (1995) Summary page 1.

## Indications for use
The Schwartz Electro-Optics, Inc. Crystalase 755 DP will be indicated for removal of tattoos of various types and colors, as well as epidermal, pigmented and vascular lesions. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. seeks no new indications for the Crystalase 755 DP laser system.

Source page: https://510kreport.com/device/K980710
Methodology: https://510kreport.com/methodology