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Apolomed HS-816

by Shanghai Apolo Medical Technology Co., Ltd

Ref 8165Model HS-816

Apolomed HS-816 is a device classified as Class IIb in the EU and Class II in the US made by Shanghai Apolo Medical Technology Co., Ltd, registered in EUDAMED on 7 May 2025 (Basic UDI-DI B-06970745918165), cleared under FDA 510(k) K200118 on 17 Apr 2020 and listed in FDA GUDID since 21 Jul 2020 (UDI-DI 06970745918165), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200118

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06970745918165 Basic UDI-DI 06970745918165UDI-DIDate7 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06970745918165 UDI-DI Date21 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK200118 Date17 Apr 2020IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06970745918165 registered 7 May 2025 Active
  • FDA 510(k) K200118 decided 17 Apr 2020 Active
  • FDA GUDID UDI-DI 06970745918165 listed 21 Jul 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200118
  2. Listed FDA GUDID 06970745918165
  3. Registered EUDAMED B-06970745918165

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  • Withdrawn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
Diode Laser Therapy Devices EUDAMED
Apolomed GUDID
Generic name
Dermatological diode laser system
Model / reference
HS-816, 8165
Primary DI / UDI-DI
06970745918165
Basic UDI-DI
B-06970745918165
510(k) Number
FDA product code
GEX
EMDN code
Z12011016 Diode surgical laser
GMDN term
Dermatological diode laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
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: Dermatological diode laser system

Similar devices in this category

Other devices filed under DIODE SURGICAL LASER.

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Properties

  • Reusable
  • Prescription use
  • Serial number
  • Expiration date
Other properties (19, all answered No)