Technolas Perfect Vision GmbH

Address:Messerschmittstr 1+3,Munchen Bavaria,DE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Keratome, Ac-Powered (HNO) (3) Ophthalmic Femtosecond Laser (OOE) (3) Laser, Ophthalmic (HQF) (2)

Premarket Exempt

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MICROKERATOME Disposable Tubing - 04050555000839 Catalog Number : 5070063

Device Description : Provides a connection between the microkeratome head and the vacuum (or suction) Provides a connection between the microkeratome head and the vacuum (or suction) pump. The function of the tubing is to provide a conduit for suction to the eye during lamellar surgery.

Device Class : 1

Duns Number: 341325716

Premarket Exempt : No

Product Code : HNO

Prescription Use : No

Device Count : 1

ACCUGLIDE® Disposable Blade - 04050555000976 Catalog Number : 5070060

Device Description : Disposable blades for HANSATOME® Microkeratome.

Device Class : 1

Duns Number: 341325716

Premarket Exempt : No

Product Code : HNO

Prescription Use : No

Device Count : 1

Zyoptix® XP Microkeratome Disposable Blades - 04050555000983 Catalog Number : 5070070

Device Description : Disposable blades for ZYOPTIX® XP Microkeratome.

Device Class : 1

Duns Number: 341325716

Premarket Exempt : No

Product Code : HNO

Prescription Use : No

Device Count : 1

Patient Interface 125 Kit - 04050555000990 Catalog Number : 90000115

Device Description : Patient Interface Kit for VICTUS™ Femtosecond Laser Platform (software version 2 Patient Interface Kit for VICTUS™ Femtosecond Laser Platform (software version 2.7 and higher).Kit consists of Patient Interface 125 and Suction Clip 125.

Device Class : 2

Duns Number: 341325716

Premarket Exempt : No

Product Code : HQF, OOE

Prescription Use : No

Device Count : 1

VICTUS™ Femtosecond Laser Platform - 04050555002895 Catalog Number : 14000

Device Description : The laser system is an ophthalmologic system based on femtosecond technology. It The laser system is an ophthalmologic system based on femtosecond technology. It is used to treat a wide variety of ophthalmologic indications.

Device Class : 2

Duns Number: 341325716

Premarket Exempt : No

Product Code : OOE

Prescription Use : No

Device Count : 1

VICTUS VERAFIT Patient Interface Kit - 04050555004165 Catalog Number : 90000200TPV

Device Class : 2

Duns Number: 341325716

Premarket Exempt : No

Product Code : HQF, OOE

Prescription Use : No

Device Count : 1

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