# K970461: Cell Robotics ER: Yag Surgical Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cell Robotics, Inc.
- Decided: Jul 11, 1997 after 155 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.
16 later devices descend from it; 3 cite it directly.
0 of 18 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 1.

## Most influential descendants
- K032599: Medical Laser Technologies, LLC MTL Erbium:Yag Laser System (2003), 13 descendants of its own
- K110897: Cortex CO2 / ER:Yag Laser System (2011), 2 descendants of its own
- K110502: Triplex ER. Yag / ND: Yag System (2011), 2 descendants of its own
- K110304: Apex ER. Yag / Ipl System (2011), 2 descendants of its own
- K063867: Cutera ER:Ysgg Laser Handpiece (2007), 2 descendants of its own

## Indications for use
The Cell Robotics, Inc. unnamed Er:YAG Surgical laser is indicated for use in small and large joint Arthroscopy, including microdiscectomies, endoscopic procedures and general surgical procedures for cutting (incision / excision), vaporizing and coagulation of soft tissues, including skin, subcutaneous tissue, muscle, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

Source page: https://510kreport.com/device/K970461
Methodology: https://510kreport.com/methodology