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CuRAS Set Package QND-C1

by CLASSYS Inc.

Ref QND-C1

CuRAS Set Package QND-C1 is a device classified as Class IIb in the EU and Class II in the US made by CLASSYS Inc., registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI B-08800016903805), cleared under FDA 510(k) K173038 on 1 Dec 2017 and listed in FDA GUDID since 30 Oct 2024 (UDI-DI 08800016903805), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173038

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800016903805 Basic UDI-DI 08800016903805UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800016903805 UDI-DI Date30 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173038 Date1 Dec 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800016903805 registered 16 Jun 2026 Active
  • FDA 510(k) K173038 decided 1 Dec 2017 Active
  • FDA GUDID UDI-DI 08800016903805 listed 30 Oct 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173038
  2. Listed FDA GUDID 08800016903805
  3. Registered EUDAMED B-08800016903805

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  • Withdrawn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

Trade name
CuRAS hybrid EUDAMED
CuRAS Set Package GUDID
Generic name
Dermatological frequency-doubled solid-state laser system
Device name
Q-Switched Nd:YAG laser system
Model / reference
QND-C1
Primary DI / UDI-DI
08800016903805
Basic UDI-DI
B-08800016903805
510(k) Number
FDA product code
GEX
EMDN code
Z12011017 Neodymium surgical laser
GMDN term
Dermatological frequency-doubled solid-state laser system
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

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.

Related devices

Category: Dermatological frequency-doubled solid-state laser system

Cleared under the same submission (K173038)

and 8 more cleared under K173038

Similar devices in this category

Other devices filed under NEODYMIUM SURGICAL LASER.

Other devices from CLASSYS Inc.

See all devices from CLASSYS Inc. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)