Data / Medical devices / Denmark / Norlase Aps
Norlase Aps: FDA-registered device maker in Ballerup Hovedstaden, Denmark, 4 510(k) clearances
Norlase Aps is registered with the FDA (registration 3015658550) in Ballerup Hovedstaden, Denmark. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015658550
- Address
- Brydehusvej 13, Ballerup Hovedstaden, Denmark, 2750
- Owner or operator
- Norlase ApS (10061124)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 27, 2019
- Registered through
- 2026
- Brand names listed
- ECHO, LEAF, LION, LYNX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Ophthalmic | HQF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| October 25, 2024 | K242397 | LYNX Photocoagulator | HQF | Substantially Equivalent | Norlase Aps | accessdata.fda.gov |
| October 11, 2022 | K222157 | ECHO Photocoagulator | HQF | Substantially Equivalent | Norlase | accessdata.fda.gov |
| August 11, 2020 | K201623 | LION Photocoagulator | HQF | Substantially Equivalent | Norlase Aps | accessdata.fda.gov |
| May 3, 2019 | K190083 | Leaf Photocoagulator | HQF | Substantially Equivalent | Norlase Aps | accessdata.fda.gov |
Compare with other makers
Updated October 25, 2024. 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.