FDA device listing

Donald Trump,DR DEAN EDELL,Elizabeth Arden,ELLEN TRACY,INVISIBLE BIFOCAL,I-OPTIX,JILL STUART,JOAN RIVERS,LEVI'S,PAULA…

FDA device listing 1389702155 · ACTION EYEWEAR CORP.

Key facts

Proprietary names Donald Trump,DR DEAN EDELL,Elizabeth Arden,ELLEN TRACY,INVISIBLE BIFOCAL,I-OPTIX,JILL STUART,JOAN RIVERS,LEVI'S,PAULA DEEN,PERRY ELLIS,ZOOM
Owner/operator ACTION EYEWEAR CORP.
Owner/operator number 9005980
Product codes HOI
Device names HOI - Spectacle, Magnifying
Device class Class I
Classification regulations (21 CFR) 886.5840
Review panels Ophthalmic
Registered establishments Action Eyewear Corp., ACTION EYEWEAR CORP.
Establishment registrations 3002720892, 3006112861
FEI numbers 3002720892, 3006112861
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings