Skip to content

Catalys System Catalys-U

by OptiMedica Corp.

Catalys System Catalys-U is a Class II device made by OptiMedica Corp., listed in FDA GUDID since 2 Sep 2016 (UDI-DI 05050474609792), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05050474609792 UDI-DI Date2 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Catalys System
Generic name
Femtosecond ophthalmic solid-state laser system
Model / Ref / Catalog
CATALYS-U
Primary DI / UDI-DI
05050474609792
FDA product code
OOE
GMDN term
Femtosecond ophthalmic solid-state laser system
Device class
Class II
Regulation number
886.4390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Femtosecond ophthalmic solid-state laser system

Other devices from OptiMedica Corp.

See all devices from OptiMedica Corp. →

Properties

  • Supplied sterile
  • Prescription use
  • Serial number
Other properties (12, all answered No)