CO2 Laser Machine (Monica-I,Monica-II)
Device Facts
| Record ID | K260974 |
|---|---|
| Device Name | CO2 Laser Machine (Monica-I,Monica-II) |
| Applicant | Nanjing Bestview Laser S&T Co., Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | May 7, 2026 |
| 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.
