# K190083: Leaf Photocoagulator

- Pathway: 510(k) (Traditional)
- Applicant: Norlase Aps
- Decided: May 3, 2019 after 106 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894841 (1989). 21 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152603: Green Laser Photocoagulator GYC-500, Nidek Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K201623: LION Photocoagulator (2020), 1 descendant of its own
- K251507: Integre Lio (2026), 0 descendants of its own
- K222157: ECHO Photocoagulator (2022), 0 descendants of its own

## Indications for use
The Norlase Leaf Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.

Source page: https://510kreport.com/device/K190083
Methodology: https://510kreport.com/methodology