# K973576: Epulse Model 2940 ER:Aser ER:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Epulse Technologies, Inc.
- Decided: Dec 9, 1997 after 90 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: 2 generations back to K954013 (1996). 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)
- K954013: Trilase 2940 Erbium Laser, Schwartz Electro-Optics, Inc. (1996) Summary page 2.
- K961748: Medlite/Erbium Laser System, Continuum Biomedical, Inc. (1996) Summary page 2.

## Indications for use
The Er:aser™ laser is intended for coagulation, ablation, vaporization, or cutting of. soft tissue in dermatology and plastic surgery, including aesthetic surgery and skin resurfacing.

Source page: https://510kreport.com/device/K973576
Methodology: https://510kreport.com/methodology