SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS
FDA 510(k) clearance K152889 · decided 2015-12-30
Clearance details
- K-number
- K152889
- Device name
- SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS
- Applicant
- Biorenew Labs, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-09-30
- Decision date
- 2015-12-30
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- OLP
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hermosa Beach, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.