TRIA FAN SYSTEM
FDA 510(k) clearance K130459 · decided 2013-10-25
Clearance details
- K-number
- K130459
- Device name
- TRIA FAN SYSTEM
- Applicant
- Tria Beauty, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-02-22
- Decision date
- 2013-10-25
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- ONG
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington D.C., DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.