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PASCAL Synthesis TwinStar PASCAL Synthesis 577 /638

by Topcon Medical Laser Systems, Inc. 2 variants

PASCAL Synthesis TwinStar PASCAL Synthesis 577 /638 (SA-06288) is a Class II device made by Topcon Medical Laser Systems, Inc., cleared under FDA 510(k) K170409 on 12 Sep 2017 and listed in FDA GUDID since 4 Oct 2017 (UDI-DI 00855005006188), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K170409

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 Number00855005006188 UDI-DI Date4 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170409 Date12 Sep 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170409 decided 12 Sep 2017 Active
  • FDA GUDID UDI-DI 00855005006188 listed 4 Oct 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170409
  2. Listed FDA GUDID 00855005006188

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  • Withdrawn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 TwinStar
Generic name
Ophthalmic solid-state laser system, photodisruption
Model / Ref / Catalog
PASCAL Synthesis 577 /638, SA-06288
Primary DI / UDI-DI
00855005006188
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 (K170409)

and 1 more cleared under K170409

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)