Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007606649

FEI Number

3003691824

Entity Name

TECHNOLAS PERFECT VISION GMBH

City/State/Country

Munchen Bavaria, DE

Establishment Address

Messerschmittstr 1+3, Munchen Bavaria 80992, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Technolas Perfect Vision GmbH (Owner Number: 10029369)

Owner / Operator Contact Address

Messerschmittstr. 1 + 3, Munich, DE-BY 80992, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P990027

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
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2014-04-22
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2011-02-01
NCF	Aberrometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2009-05-12
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2016-09-12
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2011-02-01
LZS	Excimer Laser System	Unknown	Class 3	N/A	2009-05-06

Official Correspondent

No official correspondent registered.

US Agent Details

Margaret Wood Business: BAUSCH & LOMB INCORPORATED Email: FDADeviceReg@bausch.com Phone: (864) 3206017

Related Public Records

Same Entity

Technolas Perfect Vision GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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-1515-2015	Abbott Medical Optics, Inc.	2	OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007606649. Last updated year: 2026. Please use registration number 3007606649 when referencing this establishment in official correspondence.