Skip to content

Catalys System 0160-9500

by OptiMedica Corp.

Catalys System 0160-9500 is a femtosecond ophthalmic solid-state laser system (FDA Class II; FDA product code OOE, Ophthalmic femtosecond laser) made by OptiMedica Corp., listed in FDA GUDID since 19 Aug 2020 (UDI-DI 05050474709508), 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 Number05050474709508 UDI-DI Date19 Aug 2020ListedStatusListed 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  • Withdrawn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
0160-9500
Primary DI / UDI-DI
05050474709508
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

  • Prescription use
  • Serial number
Other properties (13, all answered No)