Medical Device Manufacturer · US , Las Vegas , NV

Foreo, Inc.

10 submissions · 10 cleared · Since 2016
10
Total
10
Cleared
0
Denied

Foreo, Inc. — FDA 510(k) Submissions

Foreo, Inc. has submitted 10 FDA 510(k) premarket notifications since 2016, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Light Based Over The Counter Wrinkle Reduction, Stimulator, Transcutaneous Electrical, Aesthetic Purposes, Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction, Laser, Comb, Hair, Over-the-counter Powered Light Based Laser For Acne . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
FAQ? (LED Panel); FAQ? (Dual LED Panel)
K253683 · OHS Light Based Over The... · General & Plastic Surgery
Feb 2026 91d
FAQ? (302)
K242747 · OAP Laser, Comb, Hair · General & Plastic Surgery
Dec 2024 90d
Luna 4 plus
K241102 · OHS Light Based Over The... · General & Plastic Surgery
Aug 2024 120d
FAQ? (102)
K240616 · PAY Over-the-counter... · Physical Medicine
Jul 2024 132d
BEAR 2 Body
K232242 · NFO Stimulator,... · Neurology
May 2024 290d
FAQ? 201, FAQ? 202
K240378 · OHS Light Based Over The... · General & Plastic Surgery
Apr 2024 72d
PEACH 2, PEACH 2 Duo, PEACH 2 go
K231977 · OHT Light Based... · General & Plastic Surgery
Sep 2023 84d
FAQ 101
K222012 · PAY Over-the-counter... · General & Plastic Surgery
Apr 2023 271d
BEAR and BEAR mini
K200803 · NFO Stimulator,... · Neurology
Jul 2020 126d
ESPADA Acne-Clearing Blue Light Pen
K162450 · OLP Over-the-counter Powered... · General & Plastic Surgery
Nov 2016 90d
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