FDA device listing

Retitrack

FDA device listing 1078030141 · C. Light Technologies, Inc.

Key facts

Proprietary names Retitrack
Owner/operator C. Light Technologies, Inc.
Owner/operator number 10088349
Premarket submissions K222484
Product codes HLL
Device names HLL - Monitor, Eye Movement
Device class Class II
Classification regulations (21 CFR) 886.1510
Review panels Ophthalmic
Registered establishments C. LIGHT TECHNOLOGIES, INC.
Establishment registrations 3027593072
FEI numbers 3027593072
Establishment operations Complaint File Establishment, Manufacturer, Specification Developer
Registration valid through 2026

At a glance

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

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