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Lamp, Flourescent Black, High Output

by Dermatron Corp.

510(k) K760471

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 NumberK760471 Date15 Sep 1976ClearedStatusActive

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  • Withdrawn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 a Light, Ultraviolet, Dermatological, classified under FDA regulation 878.4630. It is a high-output fluorescent lamp designed to emit ultraviolet light for dermatological applications, specifically within the field of general and plastic surgery.

The Fluorescent Black High Output Lamp is supplied as a reusable medical device and has received FDA 510(k) clearance under the product code FTC. It was first authorized in 1976 and is intended for use in controlled clinical settings where ultraviolet light exposure is required for dermatological procedures. No additional sterility or single-use specifications are noted in the regulatory data.

Other devices from Dermatron 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 LAMP, FLOURESCENT BLACK, HIGH OUTPUT intended for?

    This device is a high-output fluorescent lamp designed to emit ultraviolet light for dermatological applications, specifically within the field of general and plastic surgery, and is intended for use in controlled clinical settings where ultraviolet light exposure is required for dermatological procedures.

  • Is the LAMP, FLOURESCENT BLACK, HIGH OUTPUT a single-use or reusable device?

    The Fluorescent Black High Output Lamp is supplied as a reusable medical device, as explicitly stated in the device description, with no indication of single-use design or disposal requirements in the regulatory data.

  • What regulatory pathway was used for the LAMP, FLOURESCENT BLACK, HIGH OUTPUT?

    The device received FDA 510(k) clearance under the traditional pathway, as indicated by the AUTHORIZATIONS field listing FDA_510K and the clearance_type field specifying Traditional, with a decision_code of SESE showing it was found substantially equivalent.

  • What is the product code and regulation number for the LAMP, FLOURESCENT BLACK, HIGH OUTPUT?

    The device is classified under product code FTC and regulation number 878.4630, as shown in the openfda and SPECIFICATIONS fields, which link it to the FDA classification for Light, Ultraviolet, Dermatological devices.

  • When was the LAMP, FLOURESCENT BLACK, HIGH OUTPUT first authorized?

    The device was first authorized in 1976, as indicated by the date_received field of 1976-08-19 and decision_date of 1976-09-15, marking its initial FDA 510(k) clearance.