# K201623: LION Photocoagulator

- Pathway: 510(k) (Special)
- Applicant: Norlase Aps
- Decided: Aug 11, 2020 after 57 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: 8 generations back to K894841 (1989). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190083: Leaf Photocoagulator, Norlase Aps (2019) Summary page 5.
- K170718: Iridex TruFocus LIO Premiere, Iridex Corporation (2017) Summary page 5.

## Most influential descendants
- K251507: Integre Lio (2026), 0 descendants of its own

## Indications for use
The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.

Source page: https://510kreport.com/device/K201623
Methodology: https://510kreport.com/methodology