← Back to catalogue
Fluobeam 800 Clinic Laser Imaging Device And Fluocase 800 Control System
FDA 510(k)Class II (US FDA 510(k))
510(k) K132475
by Fluoptics
Identifiers
- 510(k) Number
- K132475 FDA 510(k)
- FDA Product Code
- OWN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Fluobeam 800 Clinic Laser Imaging Device And Fluocase 800 Control System by Fluoptics — Class II — FDA_510K — listed in FDA 510(k)
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 | K132475 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fluoptics
Sources (1)
- FDA 510(k) K132475 24 fields · synced Jun 18, 2026