WAVELIGHT GmbH

FDA Device Registration & Listing · ERLANGEN Bavaria, DE · Registration 9710340

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9710340
FEI Number
3002483854
Entity Name
WAVELIGHT GmbH
City/State/Country
ERLANGEN Bavaria, DE
Establishment Address
AM WOLFSMANTEL 5, ERLANGEN Bavaria 91058, DE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Alcon Laboratories, Inc. (Owner Number: 1610287)
Owner / Operator Contact Address
6201 South Freeway, Fort Worth, TX 76134, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZS Excimer Laser System Unknown Class 3 N/A 2023-11-09
NCF Aberrometer, Ophthalmic Ophthalmic Class 1 886.1760 2004-02-03
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-11-09
HNO Keratome, Ac-Powered Ophthalmic Class 1 886.4370 2023-11-09
LZS Excimer Laser System Unknown Class 3 N/A 2023-11-09
HRJ Table, Instrument, Powered, Ophthalmic Ophthalmic Class 1 886.4855 2023-11-09

Official Correspondent

No official correspondent registered.

US Agent Details

Dale Schaper Email: Dale.Schaper@alcon.com Phone: (817) 5686421

Related Public Records

Same Entity

Alcon Laboratories, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013497605 Alcon Research, LLC Sinking Spring, PA, US
3003701944 OPTONOL, LTD NEVE ILAN Central, IL
3016232028 LUMITHERA, INC. Fort Worth, TX, US
3006186389 CIBA VISION JOHOR SDN.BHD., GELANG PATAH, JOHOR DARUL TAKZIM, MY
3016075957 IVANTIS, INC. Irvine, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0046-2014 Abbott Medical Optics, Inc. 3
STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Z-0047-2014 Abbott Medical Optics, Inc. 3
STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Z-0048-2014 Abbott Medical Optics, Inc. 3
STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Z-0049-2014 Abbott Medical Optics, Inc. 3
STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Z-1539-2013 Abbott Medical Optics, Inc. 3
STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710340. Last updated year: 2026. Please use registration number 9710340 when referencing this establishment in official correspondence.
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