FDA device listing

Overlaps Glowy Wand

FDA device listing 1957903331 · Lamu Incorporated

Key facts

Proprietary names Overlaps Glowy Wand
Owner/operator Lamu Incorporated
Owner/operator number 10096086
Product codes ISA
Device names ISA - Massager, Therapeutic, Electric
Device class Class I
Classification regulations (21 CFR) 890.5660
Review panels Physical Medicine
Registered establishments LAMU INCORPORATED
Establishment registrations 3039279696
FEI numbers 3039279696
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

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