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UVA Hex Unit

by Sun Shanty, Inc.

510(k) K813307

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK813307 Date31 Dec 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FTC
Device Class
Class II
Regulation
21 CFR Part 878.4630
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The UVA Hex Unit is a dermatological ultraviolet light device designed for controlled exposure to UVA radiation. It falls under the category of Light, Ultraviolet, Dermatological, and is classified as a Class II medical device. This device is intended for therapeutic applications involving controlled UVA light treatment, typically used in dermatological procedures.

The UVA Hex Unit is supplied as a reusable device and is regulated under FDA 510(k) clearance with the designation K813307. It is intended for use in clinical settings, such as general and plastic surgery environments, and adheres to regulatory standards outlined in 21 CFR 878.4630. No specific sterility or MRI safety information is provided in the data, but standard infection control practices should be followed during use.

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