Data / Medical devices / Germany / Technolas Perfect Vision GMBH

Technolas Perfect Vision GMBH: FDA-registered device maker in Munchen Bavaria, Germany, 6 510(k) clearances and 1 PMA approval

Name: Technolas Perfect Vision GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Technolas Perfect Vision GMBH is registered with the FDA (registration 3007606649) in Munchen Bavaria, Germany. It lists 5 device types. The FDA files 6 510(k) clearances and 1 PMA approval under its listings, the newest dated September 1, 2020. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Technolas Perfect Vision GMBH

FDA registration number: 3007606649
FEI number: 3003691824
Address: Messerschmittstr 1+3, Munchen Bavaria, Germany, 80992
Owner or operator: Technolas Perfect Vision GmbH (10029369)
Roles: Exporter to the US, Manufacturer
First device listed: May 6, 2009
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Aberrometer, Ophthalmic	NCF	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Excimer Laser System	LZS	3	Exporter to the US, Manufacturer	accessdata.fda.gov
Keratome, Ac-Powered	HNO	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Ophthalmic Femtosecond Laser	OOE	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Unit, Phacofragmentation	HQC	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 1, 2020	K200724	VICTUS Femtosecond Laser Platform	OOE	Substantially Equivalent	Technolas Perfect Vision GmbH	accessdata.fda.gov
June 24, 2015	K151161	VICTUS Femtosecond Laser Platform	OOE	Substantially Equivalent	Technolas Perfect Vision GmbH	accessdata.fda.gov
January 16, 2015	K141379	VICTUS FEMTOSECOND LASER PLATFORM	OOE	Substantially Equivalent	Technolas Perfect Vision GmbH	accessdata.fda.gov
February 14, 2014	K132534	VICTUS FEMTOSECOND LASER PLATFORM	OOE	Substantially Equivalent	Technolas Perfect Vision GmbH	accessdata.fda.gov
March 22, 2004	K040204	ZYOPTIX XP MICROKERATOME	HNO	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
June 19, 2002	K021640	HANSATOME EXCELLUS MICROKERATOME	HNO	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
February 23, 2000	P990027	TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)	LZS	23	February 6, 2025	accessdata.fda.gov

Compare with other makers

Updated February 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.