Data / Medical devices / Germany / WAVELIGHT GmbH

WAVELIGHT GmbH: FDA-registered device maker in PRESSATH Bavaria, Germany, 2 510(k) clearances and 2 PMA approvals

Name: WAVELIGHT GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

WAVELIGHT GmbH is registered with the FDA (registration 3003288808) in PRESSATH Bavaria, Germany. It lists 7 device types. The FDA files 2 510(k) clearances and 2 PMA approvals under its listings, the newest dated March 26, 2019. 1 recall event names it as the recalling firm. 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 WAVELIGHT GmbH

FDA registration number: 3003288808
Address: Industriegebiet Doellnitz 5, PRESSATH Bavaria, Germany, 92690
Owner or operator: Alcon Laboratories, Inc. (1610287)
Roles: Manufacturer
First device listed: February 3, 2004
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Aberrometer, Ophthalmic	NCF	1	Manufacturer	accessdata.fda.gov
Excimer Laser System	LZS	3	Manufacturer	accessdata.fda.gov
Keratome, Ac-Powered	HNO	1	Manufacturer	accessdata.fda.gov
Ophthalmic Femtosecond Laser	OOE	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Table, Instrument, Powered, Ophthalmic	HRJ	1	Manufacturer	accessdata.fda.gov
Topographer, Corneal, Ac-Powered	MMQ	1	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
March 26, 2019	K190392	WaveLight FS200 Patient Interface	GEX	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
September 30, 2014	K141476	WAVELIGHT FS200 LASER SYSTEM	OOE	Substantially Equivalent	Alcon Research, Ltd. Dba Alcon Laboratories, 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
October 10, 2003	P030008	WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM	LZS	38	January 16, 2025	accessdata.fda.gov
October 7, 2003	P020050	WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM	LZS	43	March 5, 2025	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 18, 2011	58601	Not yet classified	Terminated	WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2. The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for	The software calculating the patterns were found to has a rounding error for certain parameter ranges. These rounding errors could result in an incomplete cut in the donor or patient tissue.	accessdata.fda.gov

Compare with other makers

Updated January 16, 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.