VIVA combo RF System— 510(k) K252833
Substantially EquivalentStarmed Co., Ltd.
FDA 510(k) clearance K252833 for VIVA combo RF System, Substantially Equivalent on 2026-05-26. Applicant: Starmed Co., Ltd.. Device class: 2.
Summary
Starmed's VIVA combo RF System is filed under GEI, electrosurgical cutting and coagulation devices and accessories.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
Starmed filed from Goyang-Si, South Korea. Review took 263 calendar days (September 5, 2025 to May 26, 2026).
Clearance details
- Applicant
- Starmed Co., Ltd.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goyang-Si, KR
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More clearances from Starmed Co., Ltd.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.