FDA device listing

Folders And Injectors, Intraocular Lens (Iol)

FDA device listing 1968221764 · Alcon Laboratories, Inc.

Key facts

Owner/operator Alcon Laboratories, Inc.
Owner/operator number 1610287
Premarket submissions K003768
Product codes MSS
Device names MSS - Folders And Injectors, Intraocular Lens (Iol)
Device class Class I
Classification regulations (21 CFR) 886.4300
Review panels Ophthalmic
Registered establishments Alcon Research, LLC
Establishment registrations 1119421, 3007530141
FEI numbers 1119421, 3007530141
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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