FDA device listing

Blue Light Readers,Case + Readers Sets,Keychain Readers,Pod + Readers Sets,THINOPTICS,ThinOptics Readers,Universal Pod…

FDA device listing 1635532558 · ThinOptics

Key facts

Proprietary names Blue Light Readers,Case + Readers Sets,Keychain Readers,Pod + Readers Sets,THINOPTICS,ThinOptics Readers,Universal Pod Readers,Universal Readers
Owner/operator ThinOptics
Owner/operator number 10045974
Product codes HOI
Device names HOI - Spectacle, Magnifying
Device class Class I
Classification regulations (21 CFR) 886.5840
Review panels Ophthalmic
Registered establishments ThinOptics
Establishment registrations 3010502837
FEI numbers 3010502837
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

Browse all FDA device listings