# K980313: Schwartz Electro-Optics, Inc. CLR 2940 Erbium Crystalase

- Pathway: 510(k) (Traditional)
- Applicant: Schwartz Electro-Optics, Inc.
- Decided: Mar 19, 1998 after 51 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: 4 generations back to K954013 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974039: Schwartz Electro-Optics, Inc. CLR 2940 Erbium Crystalase, Schwartz Electro-Optics, Inc. (1998) Summary page 1.
- K971648: Sharplan Erbium: Yag Laser (4020), Sharplan Lasers, Inc. (1997) Summary page 1.

## Indications for use
As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision/excision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles.

Source page: https://510kreport.com/device/K980313
Methodology: https://510kreport.com/methodology