LipiVage
FDA 510(k) clearance K172714 · decided 2017-12-08
Clearance details
- K-number
- K172714
- Device name
- LipiVage
- Applicant
- Genesis Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-08
- Decision date
- 2017-12-08
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- MUU
- Device class
- 2
- Regulation number
- 878.5040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lewisville, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.