FDA device listing

Sunfit Lamps for Tanning,UV Lamps For Indoor Tanning Devices

FDA device listing 1922400183 · LIGHTTECH LTD.

Key facts

Proprietary names Sunfit Lamps for Tanning,UV Lamps For Indoor Tanning Devices
Owner/operator LIGHTTECH LTD.
Owner/operator number 9035094
Premarket submissions K151370
Product codes LEJ
Device names LEJ - Booth, Sun Tan
Device class Class II
Classification regulations (21 CFR) 878.4635
Review panels General & Plastic Surgery
Registered establishments LIGHTTECH LTD.
Establishment registrations 9616478
FEI numbers 3003695041
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None 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

Browse all FDA device listings