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The Tracker / August 2026 / K253859

510(k) cleared

Scarlet Pro (Scarlet Pro)

VIOL Co., Ltd. · Aug 27, 2026 · K253859

FDA cleared the Scarlet Pro (Scarlet Pro) from VIOL Co., Ltd. on Aug 27, 2026 under K253859, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 3, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for VIOL Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253859?

K253859 is the FDA 510(k) for Scarlet Pro (Scarlet Pro), submitted by VIOL Co., Ltd.. FDA's decision date was Aug 27, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Scarlet Pro (Scarlet Pro)?

VIOL Co., Ltd., based in Gyeonggi-Do, is the applicant of record for K253859.

How long did the K253859 review take?

FDA received the submission on Dec 3, 2025 and issued its decision on Aug 27, 2026, 267 days later.

← All decisions in August 2026