StarFormer (M008-3T)
FDA 510(k) clearance K241785 · decided 2025-03-27
Clearance details
- K-number
- K241785
- Device name
- StarFormer (M008-3T)
- Applicant
- Fotona D.O.O.
- Decision
- Substantially Equivalent
- Date received
- 2024-06-20
- Decision date
- 2025-03-27
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- QPL
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Ljubljana, SI
- Third-party review
- No
- Expedited review
- No
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| BTL-199 (K250309) | BTL Industries, Inc. | 2025-08-07 |
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| Axon Therapy (K210021) | Neuralace Medical, Inc. | 2021-06-11 |
Recalls involving this device
No recalls on record reference this clearance.