Norlase Aps
DenmarkFDA applicant, unverified FDA FEI 3015658550
Norlase Aps is a medical device manufacturer, with 9 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 14 Nov 2026.
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 6
- FDA 510(k) 3
- Device classes
- FDA Class II 9
- Identifiers
- FDA FEI 3015658550
- DUNS 305483903
At a glance
Market reach
- United States
- FDA FEI
What Norlase Aps makes
Norlase Aps manufactures ophthalmic diode laser systems and indirect binocular laser ophthalmoscopes, including devices such as the Norlase ECHO, Leaf, and LYNX photocoagulators. These systems are designed for retinal photocoagulation and diagnostic imaging in ophthalmology, targeting conditions requiring laser treatment or visualization of the retina.
The company’s portfolio consists of Class II medical devices, authorised via FDA 510(k) and UDI registrations.
Catalogue
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
LYNX Photocoagulator Ref K242397
Regimes: 510(k) Registry: 510(k)LION Photocoagulator Ref K201623
Regimes: 510(k) Registry: 510(k)Leaf Photocoagulator Ref K190083
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3015658550
- DUNS number
- 305483903
- Address
- Brydehusvej 13, Ballerup Hovedstaden
Frequently asked questions
How many devices does Norlase Aps have in the registry?
The registry currently lists 9 devices for Norlase Aps. Devices recorded under merged duplicate company entries are counted once.
Which registries list Norlase Aps's devices?
Among its 9 most recently registered devices, Norlase Aps has devices listed in FDA 510(k) (3 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Norlase Aps's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Norlase Aps's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Norlase Aps in the registry?
The most recently registered devices listed for Norlase Aps include Norlase ECHO photocoagulator N007-9200, Norlase Leaf photocoagulator N005-9010-03, Norlase ECHO photocoagulator N007-9200-Z and Norlase LYNX photocoagulator N008-9200.