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PASCAL Synthesis PASCAL Synthesis 577

by Topcon Medical Laser Systems, Inc. 4 variants

PASCAL Synthesis PASCAL Synthesis 577 (SA-06285) is a Class II device made by Topcon Medical Laser Systems, Inc., cleared under FDA 510(k) K123542 on 15 May 2013 and listed in FDA GUDID since 15 Apr 2016 (UDI-DI 00855005006034), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K123542

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00855005006034 UDI-DI Date15 Apr 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123542 Date15 May 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123542 decided 15 May 2013 Active
  • FDA GUDID UDI-DI 00855005006034 listed 15 Apr 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2405-2016 FDA Class II initiated 15 Jul 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 supported pattern) and then enters titration mode.

Timeline

3 dated events

  1. Cleared FDA 510(k) K123542
  2. Listed FDA GUDID 00855005006034
  3. Recall initiated FDA recalls Z-2405-2016

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PASCAL Synthesis
Generic name
Ophthalmic solid-state laser system, photodisruption
Model / Ref / Catalog
PASCAL Synthesis 577, SA-06285
Description
(577) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE
Primary DI / UDI-DI
00855005006034
510(k) Number
FDA product code
GEX, HQF
GMDN term
Ophthalmic solid-state laser system, photodisruption
Device class
Class II
Regulation number
878.4810, 886.4390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic solid-state laser system, photodisruption

Cleared under the same submission (K123542)

and 8 more cleared under K123542

Similar devices

Other devices filed under FDA product code GEX (Powered laser surgical instrument).

Other devices from Topcon Medical Laser Systems, Inc.

See all devices from Topcon Medical Laser Systems, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)