FDA device listing

A+ Wave,Soft Contact Lens

FDA device listing 1539915614 · INNOVA VISION INC.

Key facts

Proprietary names A+ Wave,Soft Contact Lens
Owner/operator INNOVA VISION INC.
Owner/operator number 9058871
Premarket submissions K083288
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 Innova Vision Inc.
Establishment registrations 3026035637
FEI numbers 3026035637
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 100–999 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