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Medical Diode Laser Systems (GBOX-6H +6 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K241791
Identifiers
- 510(k) Number
- K241791 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- Models / Variants
- GBOX-6H FDA 510(k)GBOX-10D FDA 510(k)GBOX-12D FDA 510(k)GBOX-15D FDA 510(k)VELAS Pro-30B15D FDA 510(k)VELAS II-6H FDA 510(k)VELAS II-15D 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)
Medical Diode Laser Systems (GBOX-6H +6 more) by Gigaalaser Company Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 7 models — 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 | K241791 | Class II | Active |
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Manufacturer
- Manufacturer
- Gigaalaser Company Ltd.
- FDA Applicant
- Gigaalaser Company , Ltd.
Sources (1)
- FDA 510(k) K241791 24 fields · synced Jun 18, 2026