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WaveLight EX500 Excimer Laser System

by Alcon Laboratories, Inc.

PMA P030008Ref 1025, 1016

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

CE MDR PMA

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

PMA P030008↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA PMA, GUDID, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038065GMN000166HE Basic UDI-DI Date14 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00380659909412 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR PMA Approved NumberP030008 Date10 Oct 2003ApprovedStatusActive

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 found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · PMA · GUDID

Full name
WaveLight EX500 Laser
Trade Name
WaveLight EUDAMEDGUDID
Wavelight Allegretto Wave Excimer Laser System PMA
Generic Name
Excimer laser system PMA
Femtosecond ophthalmic solid-state laser system GUDID
Device Name
Ophthalmic Excimer Laser
Model / Reference
1025 EUDAMED
1016 EUDAMED
8065990941 GUDID
Primary DI / UDI-DI
00380659909412, 00380659982873
Basic UDI-DI
038065GMN000166HE, 038065GMN000165HC
PMA Number
FDA Product Code
LZS PMA
OOE GUDID
EMDN Code
Z1212020501, Z12120299
GMDN Term
Femtosecond ophthalmic solid-state laser system
Device Class
Class IIb EUDAMED
Class III PMA
Class II GUDID
Regulation Number
886.4390
EU market of registration
Belgium
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 4 fields differ

FieldEUDAMEDPMAGUDID
Generic NameEUDAMED
—
PMA
Excimer laser system
GUDID
Femtosecond ophthalmic solid-state laser system
Model / ReferenceEUDAMED
1025
1016
PMA
—
GUDID
8065990941
FDA Product CodeEUDAMED
—
PMA
LZS
GUDID
OOE
Device ClassEUDAMED
Class IIb
PMA
Class III
GUDID
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The WaveLight EX500 Excimer Laser System is an ophthalmic device designed for laser-assisted in situ keratomileusis (LASIK) procedures. It utilizes optical zones of 6.0 and 6.5 mm with an ablation treatment zone of up to 9.0 mm to reduce or eliminate hyperopic refractive errors. The system is indicated for patients 18 years of age or older who have documented stable manifest refraction.

This device is manufactured by Alcon Laboratories, Inc. and holds FDA PMA authorization. It is intended for use in clinical settings by trained professionals to address spherical and astigmatic refractive errors. Users should refer to the official labeling for specific operational parameters and patient eligibility criteria.

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the WaveLight EX500 Excimer Laser System used for?

    The system is indicated for laser-assisted in situ keratomileusis (LASIK) to reduce or eliminate hyperopic refractive errors, including astigmatism, in patients 18 years of age or older.

  • Who is a candidate for treatment with this laser?

    Candidates must be at least 18 years old and have a documented stable manifest refraction, defined as a shift of 0.50 D or less over the year prior to surgery.

  • What are the optical zone specifications for this device?

    The device utilizes optical zones of 6.0 and 6.5 mm, with an ablation and treatment zone capacity of up to 9.0 mm.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No