# K223132: Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)

- Pathway: 510(k) (Special)
- Applicant: Iridex Corporation
- Decided: Nov 9, 2022 after 37 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: 10 generations back to K894841 (1989). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123542: Pascal Synthesis (532NM/577NM) Opthalmic Laser, Topcon Medical Laser Systems, Inc. (2013) Summary page 5.

## Most influential descendants
- K251772: Navilas Laser System 577sl (156691) (2025), 0 descendants of its own

## Indications for use
Intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: (532nm) • proliferative and non-proliferative diabetic retinopathy • macular edema • choroidal neovascularization associated with wet age-related macular degeneration • age-related macular degeneration • lattice degeneration • retinal tears and detachments (577nm) • proliferative and non-proliferative diabetic retinopathy • macular edema • choroidal neovascularization associated with wet age-related macular degeneration • age-related macular degeneration • lattice degeneration • retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: (532 nm and 577nm) • iridotomy • trabeculoplasty

Source page: https://510kreport.com/device/K223132
Methodology: https://510kreport.com/methodology