PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
Device Facts
| Record ID | K003318 |
|---|---|
| Device Name | PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X |
| Applicant | Paradigm Medical Industries, Inc. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | May 22, 2001 |
| 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.
