# K973603: Schwartz Electro-Optics, Inc. Crystalase 1064/532 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Schwartz Electro-Optics, Inc.
- Decided: Dec 19, 1997 after 88 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Continuum Biomedical Medlite: named in the summary without a submission number
- (no number) Dermal.ase: named in the summary without a submission number

## Indications for use
The Schwartz Electro-Optics, Inc. CrystaLase 1064/532 will be indicated for removal of tattoos of various types and colors, epidermal and pigmented 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 1064/532.

Source page: https://510kreport.com/device/K973603
Methodology: https://510kreport.com/methodology