HGM, INC. LASERCATH (STERILE)
Device Facts
| Record ID | K860357 |
|---|---|
| Device Name | HGM, INC. LASERCATH (STERILE) |
| Applicant | Hgm, Inc. |
| Product Code | LNK · General, Plastic Surgery |
| Decision Date | Apr 7, 1986 |
| 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.
