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intenseIR 18073

by Vydence Medical

Ref 18073

intenseIR 18073 is a device classified as Class IIb in the EU and Class II in the US made by Vydence Medical, registered in EUDAMED on 21 May 2026 (Basic UDI-DI B-07898961835099), cleared under FDA 510(k) K171443 on 20 Apr 2018 and listed in FDA GUDID since 27 May 2024 (UDI-DI 07898961835099), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171443

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07898961835099 Basic UDI-DI 07898961835099UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07898961835099 UDI-DI Date27 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171443 Date20 Apr 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07898961835099 registered 21 May 2026 Active
  • FDA 510(k) K171443 decided 20 Apr 2018 Active
  • FDA GUDID UDI-DI 07898961835099 listed 27 May 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171443
  2. Listed FDA GUDID 07898961835099
  3. Registered EUDAMED B-07898961835099

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  • Withdrawn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 · GUDID

Trade name
IntenseIR® – High power Infrared light EUDAMED
intenseIR GUDID
Generic name
Light-energy skin surface treatment system applicator
Model / Ref / Catalog
18073
Primary DI / UDI-DI
07898961835099
Basic UDI-DI
B-07898961835099
510(k) Number
FDA product code
ILY
EMDN code
Z12040299 General medicine therapeutic treatment instruments - other
GMDN term
Light-energy skin surface treatment system applicator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
890.5500
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Light-energy skin surface treatment system applicator

Cleared under the same submission (K171443)

and 3 more cleared under K171443

Similar devices in this category

Other devices filed under GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER.

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Properties

  • Serial number
  • Manufacturing date
Other properties (21, all answered No)