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Dermalux Flex MD

by Aesthetic Technology, Ltd. 2 variants

510(k) K202028

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

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) K202028↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK202028 Date16 Dec 2020ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202028 decided 16 Dec 2020 Active
  • EUDAMED Active

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
ILY
Device class
Class II
Regulation
21 CFR Part 890.5500
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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 Dermalux Flex MD is a Light-Emitting Diode (LED) Device for skin rejuvenation and treatment of mild to moderate acne vulgaris, as classified under the Physical Medicine category. It delivers targeted light therapy to promote collagen production, reduce inflammation, and improve skin texture through specific wavelength emissions.

This device is supplied as a single-use or reusable (depending on manufacturer instructions) medical instrument, intended for use in clinical or professional settings such as dermatology clinics or aesthetic treatment centres. It operates under FDA 510(k) clearance and MDD compliance, with no explicit MRI safety restrictions noted. The device is available in a standard configuration, with no additional size or variant specifications provided.

Similar devices

Other devices filed under FDA product code ILY (Lamp, Infrared, Therapeutic Heating).

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