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CeramOptec Leonardo® Duster, Set

by Ceram Optec, Inc. EUDAMEDGUDID

Active European Union

Ref SFL1940nm60W

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number404905955NP Basic UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049059301177 UDI-DIDate25 Sep 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
CeramOptec
Generic Name
General/multiple surgical solid-state laser system
Device Name
Leonardo® Duster, Set
Model / Ref / Catalog
SFL1940nm60W, Leonardo® Duster, Set
Primary DI / UDI-DI
04049059301177
Basic UDI-DI
404905955NP
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011006 Diode–pumped solid–state (dpss) surgical laser
GMDN Term
General/multiple surgical solid-state laser system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810
Medical Purpose
Leonardo® Duster is a medical laser system, designed for soft tissue treatment in urology and lithotripsy treatment. It delivers laser light through medical optical fibers to perform incision, excision, resection, vaporization, ablation, hemostasis or coagulation at the application site during surgical (endoscopic/laparoscopic) procedures and for fragmentation, dusting and other laser lithotripsy treatment methods.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SFL1940nm60W
GUDID
Leonardo® Duster, Set
Device ClassEUDAMED
Class IIb
GUDID
Class II

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No