FDA.reportPublic FDA data

510(k) K201623

Device
LION Photocoagulator
Applicant
Norlase Aps
510(k) number
K201623
Product code
HQF
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-11
Date received
2020-06-15
Regulation
886.4390
Classification name
Laser, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jan Forstberg
Address
Brydehusvej 30 2750 Ballerup DK

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HQF#

510(k), Device, Applicant table
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K233911VISULAS combiCarl Zeiss Meditec, AG2024-09-06
K232417MR Q; MR Q SUPINE; MR Q SLTMeridian AG2024-01-25
K230722Eagle deviceBelkin Vision, Ltd.2023-12-08
K232051VISULAS greenCarl Zeiss Meditec2023-10-24
K230350VISULAS yagCarl Zeiss Meditec, Inc.2023-09-22
K231011Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulseMeridian AG2023-09-12
K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)Iridex Corporation2023-02-23
K220974R:GENLutronic Vision, Inc.2022-12-27
K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation2022-11-09