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Pico Legend

by Ami Inc.

Ref AMI-CL-1011Model PICO LEGEND

Pico Legend (AMI-CL-1011) is a medical device (EU MDD Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument; EMDN category neodymium surgical laser) made by Ami Inc., registered in EUDAMED on 14 Jun 2024 (Basic UDI-DI B-08800042100292), cleared under FDA 510(k) K233007 on 12 Jun 2024 and listed in FDA GUDID since 10 Jun 2025 (UDI-DI 08800042100292), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233007

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800042100292 UDI-DI Date10 Jun 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08800042100292 Basic UDI-DI 08800042100292UDI-DIDate14 Jun 2024RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK233007 Date12 Jun 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800042100292 registered 14 Jun 2024 Active
  • FDA 510(k) K233007 decided 12 Jun 2024 Active
  • FDA GUDID UDI-DI 08800042100292 listed 10 Jun 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K233007
  2. Registered EUDAMED B-08800042100292
  3. Listed FDA GUDID 08800042100292

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  • Withdrawn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

Generic name
General/multiple surgical frequency-doubled solid-state laser system
Device name
Picosecond Nd:YAG Laser
Model / reference
PICO LEGEND, AMI-CL-1011
Primary DI / UDI-DI
08800042100292
Basic UDI-DI
B-08800042100292
510(k) Number
FDA product code
GEX
EMDN code
Z12011017 Neodymium surgical laser
GMDN term
General/multiple surgical 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
Netherlands
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.

Manufacturer details

EUDAMED SRN
KR-MF-000017522
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under NEODYMIUM SURGICAL LASER.

Other devices from Ami Inc.

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Properties

  • Serial number
  • Manufacturing date
Other properties (21, all answered No)