C100 WRINKLE REDUCTION DEVICE
FDA 510(k) clearance K112362 · decided 2012-08-14
Clearance details
- K-number
- K112362
- Device name
- C100 WRINKLE REDUCTION DEVICE
- Applicant
- Silver Bay, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-08-17
- Decision date
- 2012-08-14
- Days to decision
- 363 days
- Clearance type
- Traditional
- Product code
- OHS
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Knoxville, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.