Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces
FDA 510(k) clearance K183610 · decided 2019-03-12
Clearance details
- K-number
- K183610
- Device name
- Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces
- Applicant
- Bovie Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-12-26
- Decision date
- 2019-03-12
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Clearwater, FL, 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.