# PASCAL Synthesis PASCAL Synthesis 577

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/pascal-synthesis-sa-06285>
- Manufacturer: [Topcon Medical Laser Systems, Inc.](https://devicerts.com/manufacturers/topcon-medical-laser-systems-inc) (United States, FDA 510(k) applicant)
- Device class: Class II (US FDA)
- FDA product code: GEX, HQF
- GMDN: Ophthalmic solid-state laser system, photodisruption (16947)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00855005006034 · listed 2016-04-15 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K123542 · decision 2013-05-15 · decision SESE · status: Active · from GUDID

## Recalls

- Z-2405-2016 · Class II · terminated · initiated 2016-07-15: 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 supported pattern) and then enters titration mode.

## Identity

- Trade name: PASCAL Synthesis [FDA GUDID (AccessGUDID)]
- Generic name: Ophthalmic solid-state laser system, photodisruption [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: PASCAL Synthesis 577 [FDA GUDID (AccessGUDID)]; SA-06285 [FDA GUDID (AccessGUDID)]
- Description: (577) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00855005006034 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K123542 [FDA GUDID (AccessGUDID)]
- FDA product code: GEX [FDA GUDID (AccessGUDID)]; HQF [FDA GUDID (AccessGUDID)]
- GMDN term: Ophthalmic solid-state laser system, photodisruption (16947) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 878.4810 [FDA GUDID (AccessGUDID)]; 886.4390 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: PASCAL Synthesis PASCAL Synthesis 577, Topcon Medical Laser Systems, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/pascal-synthesis-sa-06285 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/pascal-synthesis-sa-06285.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/pascal-synthesis-sa-06285
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.