TS-RF Generator (STS10)
FDA 510(k) clearance K251566 · decided 2025-11-17
Clearance details
- K-number
- K251566
- Device name
- TS-RF Generator (STS10)
- Applicant
- Starmed Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-05-22
- Decision date
- 2025-11-17
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Goyang-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.