FDA device listing

Extended Depth Of Focus Intraocular Lens

FDA device listing 1596526079 · Alcon Laboratories, Inc.

Key facts

Owner/operator Alcon Laboratories, Inc.
Owner/operator number 1610287
Product codes POE
Device names POE - Extended Depth Of Focus Intraocular Lens
Device class Class III
Classification regulations (21 CFR) 886.3600
Review panels Ophthalmic
Registered establishments Alcon Research, LLC
Establishment registrations 1119421, 3007530141
FEI numbers 1119421, 3007530141
Establishment operations U.S. Manufacturer of Export Only Devices
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

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