Scarlet Pro (Scarlet Pro)— 510(k) K253859
Substantially EquivalentVIOL Co., Ltd.
FDA 510(k) clearance K253859 for Scarlet Pro (Scarlet Pro), Substantially Equivalent on 2026-08-27. Applicant: VIOL Co., Ltd.. Device class: 2.
Summary
VIOL's Scarlet Pro is filed under product code GEI, electrosurgical cutting and coagulation devices and accessories. The record gives no model number other than the name itself and no further description.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel. The submission was a Traditional 510(k).
VIOL filed from Gyeonggi-Do, South Korea. The decision came 267 calendar days after FDA received it (December 3, 2025 to August 27, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- VIOL 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
- Gyeonggi-Do, KR
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More clearances from VIOL 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.