# K123542: Pascal Synthesis (532NM/577NM) Opthalmic Laser

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Medical Laser Systems, Inc.
- Decided: May 15, 2013 after 177 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894841 (1989). 30 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092621: Pascal Streamline Photocoagulator, Topcon Medical Laser Systems, Inc. (2009) Summary page 1.
- K111108: Pascal Streamline 577 (with Accessories), Topcon Medical Laser Systems, Inc. (2011) Summary page 3.
- K121475: Txcell Scanning Laser Delivery System, Iridex Corp (2012). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K141851: Navilas Laser System (2015), 2 descendants of its own
- K223132: Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) (2022), 1 descendant of its own
- K162191: NAVILAS Laser System (2016), 1 descendant of its own
- K251772: Navilas Laser System 577sl (156691) (2025), 0 descendants of its own
- K170409: PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System (2017), 0 descendants of its own

## Recalls of this device
- Jul 15, 2016 · Class II · Z-2405-2016: Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM 

## Indications for use
The PASCAL® Synthesis Ophthalmic Scanning Laser System is 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: (532 nm) 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/K123542
Methodology: https://510kreport.com/methodology