510(k) Report

FDA applicant

Norlase Aps

Ballerup, DK4 decisions2019–20240 recalls

FDA records 4 decisions for Norlase Aps (Ballerup, DK) from 2019 to 2024: 4 510(k) clearances. All are in product code HQF (Laser, Ophthalmic). Since 2016 its 510(k)s took a median of 78 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Norlase”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Norlase Aps’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12020: 12022: 12024: 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Norlase Aps by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Norlase Aps’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HQFLaser, Ophthalmic4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 78 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 97 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K190083Leaf PhotocoagulatorNorlase Aps · 20192cite it
  • K201623LION PhotocoagulatorNorlase Aps · 20201cites it

What has FDA decided for it lately?

  • K242397LYNX PhotocoagulatorNorlase Aps · 2024
  • K222157ECHO PhotocoagulatorNorlase · 2022
  • K201623LION PhotocoagulatorNorlase Aps · 2020
  • K190083Leaf PhotocoagulatorNorlase Aps · 2019

All 3 as Norlase Aps →The one decision as Norlase →