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[Optional] 2mm-SD585

by Cynosure Lutronic Technology Corporation

Part of a family of 9 devices: see the family page

Ref [Optional] 2mm-SD585Model 8mm-Zoom-Collimated handpiece (Tip type: Stick type), 8mm-Zoom-Collimated handpiece (Tip type: [Optional] Semicircle type), [Optional] Zoom handpiece (Tip type: Stick type), [Optional] Zoom handpiece (Tip type: Semicircle type), [Optional] 2mm-SD585

[Optional] 2mm-SD585 is a Class I device made by Cynosure Lutronic Technology Corporation, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 88002918210118aK4), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88002918210118aK4 Basic UDI-DI 08800291820514UDI-DIDate6 Nov 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
HOLLYWOOD SPECTRA Accessories
Model / reference
8mm-Zoom-Collimated handpiece (Tip type: Stick type), 8mm-Zoom-Collimated handpiece (Tip type: [Optional] Semicircle type), [Optional] Zoom handpiece (Tip type: Stick type), [Optional] Zoom handpiece (Tip type: Semicircle type), [Optional] 2mm-SD585
Primary DI / UDI-DI
08800291820514
Basic UDI-DI
88002918210118aK4
EMDN code
Z12011017 Neodymium surgical laser
Device class
Class I
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
KR-MF-000047499
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

Other properties (14, all answered No)