Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
FDA 510(k) clearance K220138 · decided 2022-10-05
Clearance details
- K-number
- K220138
- Device name
- Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
- Applicant
- Led Spa
- Decision
- Substantially Equivalent
- Date received
- 2022-01-18
- Decision date
- 2022-10-05
- Days to decision
- 260 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
- Aprilia, IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.