FDA device listing

POLYCARBONATE LENS

FDA device listing 2070973610 · YAMAMOTO KOGAKU CO., LTD.

Key facts

Proprietary names POLYCARBONATE LENS
Owner/operator YAMAMOTO KOGAKU CO., LTD.
Owner/operator number 8030300
Product codes HQG
Device names HQG - Lens, Spectacle, Non-Custom (Prescription)
Device class Class I
Classification regulations (21 CFR) 886.5844
Review panels Ophthalmic
Registered establishments YAMAMOTO KOGAKU CO., LTD.
Establishment registrations 8030300
FEI numbers 1000629909
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

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