FDA device listing

Metal presbyopia glasses, glue presbyopia glasses, mixed presbyopia glasses (metal and glue), injection molded presbyopi

FDA device listing 1576142651 · S & J Optical (Shenzhen) Ltd.

Key facts

Proprietary names Metal presbyopia glasses, glue presbyopia glasses, mixed presbyopia glasses (metal and glue), injection molded presbyopi
Owner/operator S & J Optical (Shenzhen) Ltd.
Owner/operator number 10060114
Product codes HOI
Device names HOI - Spectacle, Magnifying
Device class Class I
Classification regulations (21 CFR) 886.5840
Review panels Ophthalmic
Registered establishments S & J OPTICAL (SHENZHEN) LTD.
Establishment registrations 3015335987
FEI numbers 3015335987
Establishment operations Contract Manufacturer, Foreign Exporter, Manufacturer, Repackager/Relabeler
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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