TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001
FDA 510(k) clearance K070185 · decided 2007-08-21
Clearance details
- K-number
- K070185
- Device name
- TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001
- Applicant
- Pharos Life Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-01-19
- Decision date
- 2007-08-21
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cambridge, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.