# K964353: Cyberlase CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Feb 28, 1997 after 119 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) Heraeus LaserSonics Paragon Laser System: named in the summary without a submission number

## Indications for use
The CyberLase CO2 Laser Systems are intended for the surgical removal (i.e., excision, incision, cutting, ablation, coagulation, homeostasis or vaporization) of soft tissue in all surgical applications with the use of wavelength of 10.6um. Areas to be covered are: Head and Neck(ENT) including Uvulopalatoplasty, Neurosurgery, General / Plastic Surgery, Dermatology, Oncology, Obstetrics/Gynecology, Orthopedics, Polymethylmethacrylate(PMMA) Removal during Revision Arthroplasty Procedures, and Thoracoscopic applications.

Source page: https://510kreport.com/device/K964353
Methodology: https://510kreport.com/methodology