# K964076: Laserscope Erbium; Yag Laser System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Jan 8, 1997 after 89 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SEO Medical Trilase 2490: named in the summary without a submission number

## Indications for use
The Laserscope Erbium:YAG Laser System and Accessories are indicated for use in procedures involving cutting (incision/excision), vaporizing and coagulating soft tissue. All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Clinical Applications: Dermatology/Plastic Surgery General Surgery (Soft Tissue) Genitourinary Gynecology ENT Soft Tissue Procedures Oral and Maxillofacial Surgery Ophthalmology Podiatry

Source page: https://510kreport.com/device/K964076
Methodology: https://510kreport.com/methodology