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Pico-K

by Speclipse, Inc.

Ref PKModel PICO-K

Pico-K (PK) is a device classified as Class IIb in the EU and Class II in the US made by SPECLIPSE, Inc., registered in EUDAMED on 3 Feb 2026 (Basic UDI-DI B-08800209800003), cleared under FDA 510(k) K253342 on 24 Dec 2025 and listed in FDA GUDID since 9 Jan 2026 (UDI-DI 08800209800003), 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) K253342↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800209800003 Basic UDI-DI 08800209800003UDI-DIDate3 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800209800003 UDI-DI Date9 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK253342 Date24 Dec 2025IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800209800003 registered 3 Feb 2026 Active
  • FDA 510(k) K253342 decided 24 Dec 2025 Active
  • FDA GUDID UDI-DI 08800209800003 listed 9 Jan 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K253342
  2. Listed FDA GUDID 08800209800003
  3. Registered EUDAMED B-08800209800003

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Multi-modality skin surface treatment system generator
Device name
Nd:YAG Surgical Laser Equipment
Model / reference
PICO-K EUDAMED
PK EUDAMED
01 GUDID
Primary DI / UDI-DI
08800209800003
Basic UDI-DI
B-08800209800003
510(k) Number
FDA product code
GEX
EMDN code
Z12011017 Neodymium surgical laser
GMDN term
Multi-modality skin surface treatment system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PICO-K
PK
GUDID
01
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.

Manufacturer details

EUDAMED SRN
KR-MF-000026775
Authorised representative
Qualrep Services B.V. NL-AR-000000537

Similar devices in this category

Other devices filed under NEODYMIUM SURGICAL LASER.

Other devices from SPECLIPSE, Inc.

  • Qmode 01

    Class II

  • Picofy 01

    Class II

  • Pico Shining(Picofy) 01

    Class II

  • Pico Shining(Pico-K) 01

    Class II

See all devices from SPECLIPSE, Inc. →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)