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Medical Diode Laser Hair Removal Device

by Zhengzhou PZ Laser Slim Technology Co., Ltd. 18 variants

Ref PZ-BDT51-02, PZ-BDT66-02, Sapphire 4 MAX, PZ-BDT86-02, X-Laser 4 MAX, IMPERIA PRECISION, M-Laser, IMPERIA PRECISION PRO, HAIRCLEAN-D2, IMPERIA PRECISION MAX, MS-LSR150-01A, Sirius One, PZ-RYO03, HAIRMINATOR01, PZ-BDTA05-02, PZ-BDTA05-01, DelviaTek Laser-01, SHR 3W KI, ICONIC Diamond ICE, PZ-BDT68-06, MS-LSR100-1A, SKIN PERFECT ELITE, SP-LUMNP-02, MS-LSR80-01A, SP-LUMNP-01, PZ-BDT66-01, PZ-BDT86-01, HAIRCLEAN-D1, PZ-BDT68-07, PZ-BDT68-05

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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) K251339↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6974587460011FH Basic UDI-DI Date14 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK251339 Date25 Jul 2025IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / Reference
PZ-BDT51-02, PZ-BDT66-02, Sapphire 4 MAX, PZ-BDT86-02, X-Laser 4 MAX, IMPERIA PRECISION, M-Laser, IMPERIA PRECISION PRO, HAIRCLEAN-D2, IMPERIA PRECISION MAX, MS-LSR150-01A, Sirius One, PZ-RYO03, HAIRMINATOR01, PZ-BDTA05-02, PZ-BDTA05-01, DelviaTek Laser-01, SHR 3W KI, ICONIC Diamond ICE, PZ-BDT68-06, MS-LSR100-1A, SKIN PERFECT ELITE, SP-LUMNP-02, MS-LSR80-01A, SP-LUMNP-01, PZ-BDT66-01, PZ-BDT86-01, HAIRCLEAN-D1, PZ-BDT68-07, PZ-BDT68-05
Primary DI / UDI-DI
06974587460493, 06974587460585, 06974587460486, 06974587460561, 06974587460189, 06974587460516, 06974587460639, 06974587460271, 06974587460295, 06974587460523, 06974587460202, 06974587460622, 06974587460660, 06974587460462, 06974587460691, 06974587460684, 06974587460547, 06974587460509, 06974587460264, 06974587460448, 06974587460707, 06974587460134, 06974587460592, 06974587460714, 06974587460424, 06974587460417, 06974587460400, 06974587460554, 06974587460455, 06974587460233
Basic UDI-DI
6974587460011FH, 6974587460141FX
Direct Marketing DI
06974587460493
06974587460585
06974587460486
06974587460561
06974587460189
06974587460516
06974587460639
06974587460271
06974587460295
06974587460523
06974587460202
06974587460622
06974587460660
06974587460462
06974587460691
06974587460684
06974587460547
06974587460509
06974587460264
06974587460448
06974587460707
06974587460134
06974587460592
06974587460714
06974587460424
06974587460417
06974587460400
06974587460554
06974587460455
06974587460233
EMDN Code
Z12011016 Diode surgical laser
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000026642
Authorised representative
MedPath GmbH DE-AR-000000087

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No