QuantumStar, StarFormer M008-3T
QuantumStar, StarFormer M008-3T is a deep-tissue electromagnetic stimulation system (FDA Class II) made by FOTONA d.o.o., cleared under FDA 510(k) K241785 on 27 Mar 2025 (1 earlier submission) and listed in FDA GUDID since 12 Jun 2025 (UDI-DI 03830054238138), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03830054238138 | Date12 Jun 2025 | StatusListed |
| United States | FDA 510(k) | NumberK241785 | Date27 Mar 2025 | StatusActive |
Official records
- AccessGUDID record 03830054238138
- FDA 510(k) database K241785
- FDA 510(k) database K234061
Across registries
- FDA 510(k) K241785 decided 27 Mar 2025 Active
- FDA GUDID UDI-DI 03830054238138 listed 12 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K234061
- Cleared FDA 510(k) K241785
- Listed FDA GUDID 03830054238138
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- QuantumStar, StarFormer
- Generic name
- Deep-tissue electromagnetic stimulation system, professional
- Model / reference
- M008-3T
- Primary DI / UDI-DI
- 03830054238138
- FDA product code
- IPF, NGX, KPI, QPL
- GMDN term
- Deep-tissue electromagnetic stimulation system, professional
- Device class
- Class II
- Regulation number
- 890.5850, 876.5320, 882.5890
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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