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Quadruple Laser System - CPMT NYX PLUS
FDA 510(k)Class II (US FDA 510(k))
510(k) K222915
by Canadian Pioneer Medical Technology Corporation (Cpmt Laser)
Identifiers
- 510(k) Number
- K222915 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- Models / Variants
- : CPMT ARES FDA 510(k)CPMT NEMESIS FDA 510(k)CPMT NYX PLUS FDA 510(k)CPMT GRACE PLUS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Quadruple Laser System - CPMT NYX PLUS by Canadian Pioneer Medical Technology Corporation (Cpmt Laser) — Class II — FDA_510K — listed in FDA 510(k) — 4 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222915 | Class II | Active |
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Manufacturer
Sources (1)
- FDA 510(k) K222915 24 fields · synced Jun 18, 2026