# Norlase Aps

- Location (FDA's records): Ballerup, DK
- FDA decisions: 4 (2019–2024): 4 510(k) clearances
- Names in FDA's records: Norlase Aps (3); Norlase (1)
- Product codes: HQF (4)
- 510(k) review time since 2016: median 78 days, against 97 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Iridex Corp: 1 (https://510kreport.com/company/iridex)
- Nidek, Inc.: 1 (https://510kreport.com/company/nidek)

## Firms that cite its devices most
- Quantel Medical: 1 (https://510kreport.com/company/quantel-medical)

## Its most-cited devices
- K190083: Leaf Photocoagulator (2019), cited by 2
- K201623: LION Photocoagulator (2020), cited by 1

## Recent decisions
- K242397: LYNX Photocoagulator (Oct 25, 2024)
- K222157: ECHO Photocoagulator (Oct 11, 2022)
- K201623: LION Photocoagulator (Aug 11, 2020)
- K190083: Leaf Photocoagulator (May 3, 2019)

Source page: https://510kreport.com/company/norlase