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Marco Marco iON

by Lombart Brothers, Inc.

Marco Marco iON is a Class II device made by Lombart Brothers, Inc., listed in FDA GUDID since 2 Mar 2026 (UDI-DI 00860014277559), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860014277559 UDI-DI Date2 Mar 2026ListedStatusListed 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  • Withdrawn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
Marco
Generic name
Ophthalmic fundus camera
Model / reference
Marco iON
Primary DI / UDI-DI
00860014277559
FDA product code
PJZ
GMDN term
Ophthalmic fundus camera
Device class
Class II
Regulation number
886.1120
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code PJZ (Camera, Ophthalmic, General-Use).

Other devices from Lombart Brothers, Inc.

See all devices from Lombart Brothers, Inc. →

Properties

  • Prescription use
  • Premarket exempt
Other properties (13, all answered No)