OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM
Device Facts
| Record ID | K922497 |
|---|---|
| Device Name | OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM |
| Applicant | Trimedyne, Inc. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Mar 1, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
Regulatory Classification
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
