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Laserconn

by Sanhe Laserconn Tech Co., Ltd. 2 variants

Ref MILESTONE SMART-M

Laserconn (MILESTONE SMART-M) is a dermatological laser beam guiding handpiece (EU MDD Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Sanhe Laserconn Tech Co., Ltd., registered in EUDAMED on 13 Nov 2023 (Basic UDI-DI B-06972558160038), cleared under FDA 510(k) K222800 on 7 Nov 2022 and listed in FDA GUDID since 13 Dec 2022 (UDI-DI 06972558160038), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222800

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06972558160038 Basic UDI-DI 06972558160038UDI-DIDate13 Nov 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06972558160038 UDI-DI Date13 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK222800 Date7 Nov 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06972558160038 registered 13 Nov 2023 Active
  • FDA 510(k) K222800 decided 7 Nov 2022 Active
  • FDA GUDID UDI-DI 06972558160038 listed 13 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K222800
  2. Listed FDA GUDID 06972558160038
  3. Registered EUDAMED B-06972558160038

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  • Withdrawn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

Generic name
Dermatological laser beam guiding handpiece
Device name
Diode Laser Hair Removal System for Medical Use
Model / Ref / Catalog
MILESTONE SMART-M, Diode Laser Hair Removal System
Primary DI / UDI-DI
06972558160038
Basic UDI-DI
B-06972558160038
510(k) Number
FDA product code
GEX
EMDN code
Z12011016 Diode surgical laser
GMDN term
Dermatological laser beam guiding handpiece
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Height — 235 Millimeter
Width — 435 Millimeter
Length — 355 Millimeter

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.

Manufacturer details

EUDAMED SRN
CN-MF-000028667
Authorised representative
Prolinx GmbH DE-AR-000005129

Similar devices in this category

Other devices filed under DIODE SURGICAL LASER.

Other devices from Sanhe Laserconn Tech Co., Ltd.

See all devices from Sanhe Laserconn Tech Co., Ltd. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)