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Alma Lasers Accent B-Shape Massager Handpiece/Module
FDA 510(k)Class II (US FDA 510(k))
510(k) K082622
Identifiers
- 510(k) Number
- K082622 FDA 510(k)
- FDA Product Code
- NUV 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)
Alma Lasers Accent B-Shape Massager Handpiece/Module by Alma Lasers Ltd. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
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 | K082622 | Class II | Active |
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Manufacturer
- Manufacturer
- Alma Lasers Ltd.
- FDA Applicant
- Alma Lasers , Ltd.
Sources (1)
- FDA 510(k) K082622 24 fields · synced Jun 18, 2026