VIVA combo RF System
FDA 510(k) K183538 · Starmed Co., Ltd.
510(k) numberK183538
Submission
- Device name
- VIVA combo RF System
- Applicant
- Starmed Co., Ltd.
Goyang-Si, KR - Received
- December 19, 2018
- Decision date
- January 17, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K203795 | Star RF Electrode, VIVA RF ElectrodeGEI · Traditional | 04/01/2021SE |
| K181758 | ELRA ElectrodeKNS · Traditional | 04/11/2019SE |
| K181249 | EUSRA RF ElectrodeGEI · Traditional | 09/04/2018SE |
| K172012 | star RF Electrode, VIVA RF ElectrodeGEI · Traditional | 03/14/2018SE |
| K163450 | VIVA combo RF SystemGEI · Traditional | 03/08/2017SE |
Questions and answers
When was VIVA combo RF System cleared by the FDA?
VIVA combo RF System (K183538) received a 510(k) decision of Substantially Equivalent on January 17, 2019, 29 days after the submission was received.
What is the product code of K183538?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.