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Qualtex Light Handle and Light Handle Cover

by Deroyal Industries, Inc.

510(k) K911369

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K911369↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK911369 Date13 May 1991ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MDM
Device Class
Class I
Regulation
21 CFR Part 878.4800
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The Qualtex Light Handle and Light Handle Cover is a surgical instrument accessory designed to enhance visibility during procedures. It consists of a light handle and its protective cover, intended to illuminate the surgical field while maintaining sterility and reducing glare.

This device is supplied as a reusable component, intended for use in general and plastic surgery settings. It is not classified as MRI-safe or MRI-conditional, and no specific sterility standards are noted beyond standard surgical instrument processing. Authorised under FDA 510K clearance (K911369), it adheres to MDD and MDR compliance requirements. Storage and handling follow standard surgical instrument protocols.

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Questions

AI-generated answers, 18 Sep 2026

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

  • Is the Qualtex Light Handle and Light Handle Cover designed for single-use or can it be reused in multiple procedures?

    The Qualtex Light Handle and Light Handle Cover is explicitly designed as a reusable component. Since it is intended for surgical use, it follows standard surgical instrument processing protocols for reprocessing between procedures, ensuring proper cleaning, sterilization, and maintenance.

  • What types of surgical procedures is this device intended to assist with, and in which settings?

    This device is intended for use in general and plastic surgery procedures to enhance visibility in the surgical field. It is not tied to a specific clinical indication but rather serves as an accessory to improve illumination during operations where clear visibility is critical.

  • How should the Qualtex Light Handle and Light Handle Cover be stored, and are there any special handling instructions?

    Storage and handling follow standard surgical instrument protocols, meaning it should be kept in a clean, dry environment, protected from contamination, and stored according to manufacturer guidelines to maintain functionality and sterility before use.

  • Is the Qualtex Light Handle and Light Handle Cover compatible with MRI machines, or does it pose any risks during imaging?

    The device is not classified as MRI-safe or MRI-conditional, meaning it should not be used in or near MRI environments. Its metallic components could interfere with imaging or pose safety risks during MRI procedures.

  • What regulatory pathways does the Qualtex Light Handle and Light Handle Cover follow, and how was its compliance verified?

    The device was cleared via an FDA 510(k) submission (K911369) under the Traditional Review pathway, determined to be Substantially Equivalent (SESE) to a predicate device. It also complies with MDD (Medical Device Directive) and MDR (Medical Device Regulation) requirements, ensuring adherence to European regulatory standards.