Identifiers
- 510(k) Number
- K231718 FDA 510(k)
- FDA Product Code
- GEX 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)
Holmium Medical Laser by Allengers Global Healthcare Private Limited — Class II — MDR, MDD, FDA_510K — listed in FDA 510(k), EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
European Union Active
MDD
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231718 | Class II | Active |
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Manufacturer
- Manufacturer
- Allengers Global Healthcare Private Limited
Sources (2)
- FDA 510(k) K231718 24 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 19, 2026