DORNIER MEDILAS FIBER TOME LASER
Device Facts
| Record ID | K964760 |
|---|---|
| Device Name | DORNIER MEDILAS FIBER TOME LASER |
| Applicant | Dornier Medtech America, Inc. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Feb 19, 1997 |
| 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.
