# K971404: Schwartz Electro-Optics, Inc.  CLR 2940/Erbium Crystalase (Formerly Trilase 2940 Erbium Laser

- Pathway: 510(k) (Traditional)
- Applicant: Schwartz Electro-Optics, Inc.
- Decided: Jul 9, 1997 after 84 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 K954013 (1996). 1 ancestor in all.
57 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954013: Trilase 2940 Erbium Laser, Schwartz Electro-Optics, Inc. (1996) Summary page 5.
- (no number) Premier Centauri Erbium: named in the summary without a submission number

## Most influential descendants
- K981438: Dornier Medilas E (1998), 56 descendants of its own
- K050317: Burane XL (2005), 53 descendants of its own
- K052806: Burane (2005), 52 descendants of its own
- K082947: Lensx 550 Laser System (2009), 51 descendants of its own
- K094052: Lensx 550 Laser System. Model 550 (2010), 47 descendants of its own

## Indications for use
As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 will be 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. Specialties are: * General Surgery Plastic Surgery, Podiatry Urology Gynecology Pulmionary Surgery * Dermatology * Gastroenterology * Ophthalmology * ENT Thoracic Surgery Cral and Maxiliofacial Surgery

Source page: https://510kreport.com/device/K971404
Methodology: https://510kreport.com/methodology