FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces
K Number: K183610
·
Decision Mar 12, 2019
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
14
Review Days
76
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Basic Information
- Device Name
- Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces
- K Number
- K183610
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bovie Medical Corporation
- Date Received
- December 26, 2018
- Decision Date
- March 12, 2019
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Bovie Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K170777 | Bovie J-Plasma Precise FLEX Handpiece | May 1, 2017 | Substantially Equivalent |
| K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator | Mar 8, 2017 | Substantially Equivalent |
| K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating | Jul 29, 2016 | Substantially Equivalent |
| K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator | Jun 20, 2016 | Substantially Equivalent |
| K152777 | Bovie Disposable Bipolar Ablator | Jan 15, 2016 | Substantially Equivalent |
| K152570 | Bovie J-Plasma Precise 360 Handpiece | Nov 2, 2015 | Substantially Equivalent |
| K151325 | Bovie J-Plasma Handpiece | Aug 4, 2015 | Substantially Equivalent |
| K142975 | Bovie Ultimate High Frequency Electrosurgical Generator | Dec 12, 2014 | Substantially Equivalent |
| K134054 | BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | Mar 17, 2014 | Substantially Equivalent |
| K121441 | CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) | Jul 20, 2012 | Substantially Equivalent |