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Treatment Pack (Size S) 1013

by Carl Zeiss Meditec AG

Ref 1013Model Treatment Pack Size S, Treatment Pack Size M, Treatment Pack Size L, Treatment Pack Type KP

Treatment Pack (Size S) 1013 is a femtosecond ophthalmic solid-state laser system (EU MDR Class IIa; FDA Class II) made by Carl Zeiss Meditec AG, registered in EUDAMED on 24 Jul 2026 (Basic UDI-DI 4049471_TP0001_35) with CE/MDR certificate 1000335292 valid until 5 Jan 2027, approved under FDA PMA P150040 on 13 Sep 2016 and listed in FDA GUDID since 8 Feb 2024 (UDI-DI 04049471110135), active as of 23 Oct 2026. One FDA recall is linked to it.

Expiring Expiring in European Union. Active in United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

5 Jan 2027

CE MDR certificate

FDA recalls

None ongoing

1 closed

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH

PMA P150040

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/MDR EUDAMED Number1000335292 Date16 Sep 2026IssuedStatusExpiring expires 5 Jan 2027
United StatesGUDID listing GUDID Number04049471110135 UDI-DI Date8 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMA GUDID from GUDID NumberP150040 Date13 Sep 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4049471_TP0001_35 registered 24 Jul 2026 Active· +1 more in the status table
  • FDA PMA P150040 decided 13 Sep 2016 Active
  • FDA GUDID UDI-DI 04049471110135 listed 8 Feb 2024 Listed

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000335292 Expiring Supplemented Expires in 52 days

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    16 Sep 2026
    Expires
    5 Jan 2027
    Reason
    Add device or group
  • 1000335292 Expiring Supplemented Expires in 52 days Removed from EUDAMED

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    16 Sep 2026
    Expires
    5 Jan 2027
    Reason
    Change approved

Recalls

1 recall · FDA

    • Terminated Z-0680-2020 FDA Class II initiated 6 Dec 2018

    VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software allows the user to choose the option immediate restart or restart treatment. Suction loss can occur in phase 1 through phase 5. The software defect refers to Phase 2 (between 10% and 100% of lower lenticule cut) only. The software offers a flap cut, but due to the software issue it performs a cap cut instead of a flap cut if the user proceeds.

Timeline

6 dated events

  1. Approved FDA PMA P150040
  2. Recall initiated FDA recalls Z-0680-2020
  3. Listed FDA GUDID 04049471110135
  4. Registered EUDAMED 4049471_TP0001_35
  5. Certificate issued EUDAMED 1000335292
  6. Certificate expires EUDAMED 1000335292

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Treatment Pack EUDAMED
Treatment Pack (Size S) GUDID
Generic name
Femtosecond ophthalmic solid-state laser system
Model / reference
1013, Treatment Pack Size S, Treatment Pack Size M, Treatment Pack Size L, Treatment Pack Type KP
Primary DI / UDI-DI
04049471110135
Basic UDI-DI
4049471_TP0001_35
Unit of use DI
04049471100136
PMA number
FDA product code
HQF, HNO, OTL
EMDN code
Z1212020585 Microkeratomy instruments - consumables
GMDN term
Femtosecond ophthalmic solid-state laser system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.4390, 886.4370
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Femtosecond ophthalmic solid-state laser system

Cleared under the same submission (P150040)

Similar devices in this category

Other devices filed under INSTRUMENTS FOR MICROKERATOME SURGERY.

Other devices from Carl Zeiss Meditec AG

See all devices from Carl Zeiss Meditec AG →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)