Bovie J-Plasma Handpiece
FDA 510(k) K151325 · Bovie Medical Corporation
510(k) numberK151325
Submission
- Device name
- Bovie J-Plasma Handpiece
- Applicant
- Bovie Medical Corporation
Clearwater, FL, US - Received
- May 18, 2015
- Decision date
- August 4, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| 510(k) | Device | Decision |
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| K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces…GEI · Traditional | 03/12/2019SE |
| K180211 | FreezpointGEH · Traditional | 03/21/2018SE |
| K170777 | Bovie J-Plasma Precise FLEX HandpieceGEI · Traditional | 05/01/2017SE |
| K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…GEI · Traditional | 03/08/2017SE |
| K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…GEI · Traditional | 07/29/2016SE |
| K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator…GEI · Traditional | 06/20/2016SE |
| K152777 | Bovie Disposable Bipolar AblatorGEI · Traditional | 01/15/2016SE |
| K152570 | Bovie J-Plasma Precise 360 HandpieceGEI · Traditional | 11/02/2015SE |
| K142975 | Bovie Ultimate High Frequency Electrosurgical GeneratorGEI · Traditional | 12/12/2014SE |
| K134054 | Bovie IDS-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency…GEI · Traditional | 03/17/2014SE |
Questions and answers
When was Bovie J-Plasma Handpiece cleared by the FDA?
Bovie J-Plasma Handpiece (K151325) received a 510(k) decision of Substantially Equivalent on August 4, 2015, 78 days after the submission was received.
What is the product code of K151325?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.