# K022464: Equilase System

- Pathway: 510(k) (Traditional)
- Applicant: Equilasers, Inc.
- Decided: Nov 21, 2002 after 118 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 K990903 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990903: Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration), Laserscope (1999) Summary page 1.

## Indications for use
The Equilase system, used together with a FDA cleared fiber optic delivery system, is intended for general surgical incision/excision, vaporization, ablation and coagulation of soft tissues. All soft tissues such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands, are included.

Source page: https://510kreport.com/device/K022464
Methodology: https://510kreport.com/methodology