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WAVELIGHT GmbH

Germany · Erlangen

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

14listed device types

Class I 11Class II 2Class III 1

plus 21 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

8active device licences

Class II 6Class III 2

TWTaiwanTFDA

6valid device licences

Class I 2Class II 3Class III 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

5active ARTG entries

Class I 2IIa 1IIb 2

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

4active registrations

Class 2b 4

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States21 registration records, 1 510(k), 0 PMA, 1 excluded

Brazil1 confirmed, 0 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: WAVELIGHT GmbH · WaveLight GmbH · WAVELIGHT GMBH

FDA 510(k) clearances by year

12007 · K071183

FDA listed device types

showing 8 of 14

Excimer Laser System 1Powered Laser Surgical Instrument 1Ophthalmic Femtosecond Laser 1Aberrometer, Ophthalmic 1Camera, Still, Microsurgical 1Marker, Ocular 1Topographer, Corneal, Ac-Powered 1Device, Fixation, Ac-Powered, Ophthalmic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K071183	ALLEGRO OCULYZER	2007-07-20
BR	81869420113	VERION - UNIDADE DE REFERÊNCIA	Class II
CA	61898	ALLEGRETTO WAVE EXCIMER LASER SYSTEM	Class III
CA	71177	ALLEGRO ANALYZER	Class II
CA	73123	ALLEGRETTO WAVE EYE-Q	Class III