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eCO2 3D Static Tip 500

by Cynosure Lutronic Technology Corporation

Ref Static Tip 500Model Static Tip 120, Static Tip 300, Static Tip 500, Static Tip Set, F100 handpiece, F100 connector, F100 connector_D, F100 normal tip, F50 handpiece, F50 Normal tip, F50 Normal Tip_D, Zoom handpiece, Zoom connector, Zoom connector_D

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88002918210409aKP Basic UDI-DI 08800291821207UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800291821207 UDI-DI Date15 Apr 2026ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Static Tip 500 EUDAMED
eCO2 3D GUDID
Generic Name
Dermatological carbon dioxide laser system
Device Name
eCO2 3D Accessories
Model / Reference
Static Tip 500, Static Tip 120, Static Tip 300, Static Tip Set, F100 handpiece, F100 connector, F100 connector_D, F100 normal tip, F50 handpiece, F50 Normal tip, F50 Normal Tip_D, Zoom handpiece, Zoom connector, Zoom connector_D
Primary DI / UDI-DI
08800291821207
Basic UDI-DI
88002918210409aKP
FDA Product Code
ONG
EMDN Code
Z12011080 Laser surgery instruments - hardware accessories
GMDN Term
Dermatological carbon dioxide laser system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

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See all devices from Cynosure Lutronic Technology Corporation →

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No