Norlase ApS
Ballerup Hovedstaden, DK
NORLASE APS appears in FDA device records in Ballerup Hovedstaden, DK. FDA records list 4 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Norlase ApS between 2019 and 2024. The busiest year on record is 2019, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242397 | LYNX Photocoagulator | HQF | Substantially Equivalent | |
| K222157 | ECHO Photocoagulator | HQF | Substantially Equivalent | |
| K201623 | LION Photocoagulator | HQF | Substantially Equivalent | |
| K190083 | Leaf Photocoagulator | HQF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015658550 | 3015658550 | NORLASE APS | Brydehusvej 13, Ballerup Hovedstaden 2750 DK | 2026 | |
| 3016405041 | 3016405041 | Norlase INC | 895 Hurlingame Ave, Redwood City, CA 94063 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain