StarFormer, TightWave— 510(k) K221274
Substantially EquivalentFotona D.O.O.
FDA 510(k) clearance K221274 for StarFormer, TightWave, Substantially Equivalent on 2023-09-29. Applicant: Fotona D.O.O.. Device class: 2.
Clearance details
- Applicant
- Fotona D.O.O.
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ljubljana, SI
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