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Mobile Laser Unit (1001-N2) +3 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K251298
Identifiers
- 510(k) Number
- K251298 FDA 510(k)
- FDA Product Code
- ONO FDA 510(k)
- Models / Variants
- Mobile Laser Unit (1001-N2) FDA 510(k)Thermoguide Workstation (1100-N1) FDA 510(k)Laser Applicator (4012-N5, 4017-N2, 4017-N4) FDA 510(k)MR Introducer (4013-N6) 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)
Mobile Laser Unit (1001-N2) +3 more models by Clinical Laserthermia Systems Ab — 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 | K251298 | Class II | Active |
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Manufacturer
- Manufacturer
- Clinical Laserthermia Systems Ab
- FDA Applicant
- Clinical Laserthermia Systems, AB
Sources (1)
- FDA 510(k) K251298 24 fields · synced Jun 18, 2026