FDA device listing

Optical Insert

FDA device listing 1973503452 · Apple Inc.

Key facts

Proprietary names Optical Insert
Owner/operator Apple Inc.
Owner/operator number 10058630
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 APPLE INC.
Establishment registrations 3014343954
FEI numbers 3014343954
Establishment operations Specification Developer
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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