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FDA 510(k)

Scarlet Pro (Scarlet Pro)

K-Number: K253859 · 2026-08-27

ApplicantVIOL Co., Ltd.
Decision Date2026-08-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Scarlet Pro (Scarlet Pro) is the device name listed in this FDA 510(k) record. The listed applicant is VIOL Co., Ltd.. It received FDA 510(k) clearance on 2026-08-27 under 510(k) number K253859. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Scarlet Pro (Scarlet Pro)?

Scarlet Pro (Scarlet Pro) is a medical device that received FDA 510(k) clearance on 2026-08-27. The listed applicant is VIOL Co., Ltd.. The 510(k) number is K253859.

When did Scarlet Pro (Scarlet Pro) receive FDA 510(k) clearance?

Scarlet Pro (Scarlet Pro) received FDA 510(k) clearance on 2026-08-27, under 510(k) number K253859.

Who is the listed applicant for Scarlet Pro (Scarlet Pro)?

The FDA 510(k) record lists VIOL Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Scarlet Pro (Scarlet Pro)?

The FDA product code for Scarlet Pro (Scarlet Pro) is GEI.

Other records listing VIOL Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240897CellinewK213612SYLFIRM XK200185SYLFIRM XK180872SCARLET SRFK172023CELFIRM

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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