FDA device listing

Lenses, Soft Contact, Daily Wear

FDA device listing 1284391607 · Bausch & Lomb Incorporated

Key facts

Owner/operator Bausch & Lomb Incorporated
Owner/operator number 9913003
Premarket submissions K143632
Product codes LPL, MVN
Device names LPL - Lenses, Soft Contact, Daily Wear, MVN - Lens, Contact, (Disposable)
Device class Class II
Classification regulations (21 CFR) 886.5925
Review panels Ophthalmic
Registered establishments Bausch & Lomb Incorporated, Bausch & Lomb Ireland Limited T/A Bausch and Lomb Ireland, Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre
Establishment registrations 1123818, 1313525, 9610731, 3003365815
FEI numbers 1317628, 1000305478, 3002806454, 3003365815
Establishment operations Complaint File Establishment, Foreign Exporter, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None 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

Browse all FDA device listings