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F72T12/BL-S/SHO-O UVA Sunlamp

by Westinghouse Electric Corp.

510(k) K811586

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 NumberK811586 Date13 Aug 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  • Withdrawn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, 19 Sep 2026

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

This device is an ultraviolet dermatological light, classified as a Class II medical device under 21 CFR 878.4630. It emits UVA radiation for therapeutic or diagnostic purposes in dermatological applications, such as phototherapy or skin condition assessment.

The F72T12/BL-S/SHO-O UVA Sunlamp is supplied as a reusable device and is intended for use in clinical settings. It was granted FDA 510(k) clearance under the Traditional pathway with a Substantially Equivalent (SESE) decision, filed under the product code FTC. No specific sterility or MRI safety information is provided in the data.

Other devices from Westinghouse Electric Corp.

Questions

AI-generated answers, 19 Sep 2026

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

  • What is the primary use of the F72T12/BL-S/SHO-O UVA Sunlamp in clinical settings?

    The F72T12/BL-S/SHO-O UVA Sunlamp is designed for therapeutic or diagnostic dermatological applications, emitting UVA radiation to support phototherapy or skin condition assessment. Its classification as a Class II medical device under 21 CFR 878.4630 confirms its intended use in controlled clinical environments.

  • Is this device intended for single-use or can it be reused in a clinical setting?

    This device is explicitly labeled as reusable, meaning it is designed for repeated use in clinical settings after proper cleaning and maintenance. There is no mention of single-use requirements in the provided data.

  • What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

    The F72T12/BL-S/SHO-O UVA Sunlamp received FDA clearance through the Traditional 510(k) pathway with a *Substantially Equivalent (SESE)* decision, filed under product code *FTC*. This means the device was deemed comparable to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for its intended dermatological applications.

  • Are there any specific storage requirements mentioned for this UVA Sunlamp?

    The provided data does not specify any particular storage requirements for the F72T12/BL-S/SHO-O UVA Sunlamp. However, as a reusable medical device emitting UVA radiation, it should be stored in a clean, dry environment away from direct sunlight or sources of contamination to maintain its functionality and hygiene.