Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003288808

FEI Number

3003288808

Entity Name

WAVELIGHT GmbH

City/State/Country

PRESSATH Bavaria, DE

Establishment Address

Industriegebiet Doellnitz 5, PRESSATH Bavaria 92690, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Alcon Laboratories, Inc. (Owner Number: 1610287)

Owner / Operator Contact Address

6201 South Freeway, Fort Worth, TX 76134, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141476

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
MMQ	Topographer, Corneal, Ac-Powered	Ophthalmic	Class 1	886.1350	2023-11-09
NCF	Aberrometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2004-02-03
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
LZS	Excimer Laser System	Unknown	Class 3	N/A	2023-11-09
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	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
K170322	Abbott Medical Optics, Inc.	Catalys Precision Laser System	2017-05-19

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.

Similar Registrations

Registration Number	Establishment Name	Location
3043625014	AI4EYES MEDICAL TECHNOLOGIES, INC.	Saint-Laurent Quebec, CA
3007177447	HITTECH MULTIN BV	Den Haag Zuid-Holland, NL
9611269	OCULUS OPTIKGERATE GMBH	WETZLAR Hesse, DE
1000391004	KEELER LTD.	WINDSOR, BERKSHIRE Windsor and Maidenhead, GB
3021343245	SHENZHEN CERTAINN TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003288808. Last updated year: 2026. Please use registration number 3003288808 when referencing this establishment in official correspondence.