Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012104022

FEI Number

3012104022

Entity Name

FOREO INC

City/State/Country

Las Vegas, NV, US

Establishment Address

1525 E Pama Lane, Las Vegas, NV 89119, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

FOREO INC (Owner Number: 10050498)

Owner / Operator Contact Address

1525 E Pama Lane, Las Vegas, NV 89119, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200803

PMA Number

N/A

All Registered Proprietary Names

ISSA MINI SET ISSA 4 BABY ISSA MINI 2 SENSITIVE ISSA PLAY ISSA SENSTIVE ISSA 4 ISSA Hybrid Wave Brush Head Lavender ISSA MIKRO ISSA 4 PLUS ISSA baby Brush Head Pearl Pink ISSA PRO SET ISSA 3 ISSA COMPACT ISSA 2 SENSITIVE SET ISSA BABY ISSA 2 ISSA HYBRID BRUSH HEAD ISSA BRUSH HEAD ISSA baby Brush Head Bubble Blue ISSA KIDS SENSITIVE ISSA KIDS ISSA MINI ISSA HYBRID ISSA baby Brush Head Kiwi Green ISSA MINI 3 ISSA 4 SMILE FAQ 101 KIWI derma FAQ LED Panel ISSA Teeth Whitening Device BEAR 2 Body FAQ 302 ESPADA 2 ESPADA 2 PLUS BEAR MINI BEAR Bear 2 eyes & lips Bear 2 Bear 2 go

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2015-11-24
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2023-07-25
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2023-07-25
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2023-11-30
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2026-02-25
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2026-02-25
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2026-04-28
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2024-05-14
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2024-12-16
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2016-12-14
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2021-03-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FOREO INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012104022. Last updated year: 2026. Please use registration number 3012104022 when referencing this establishment in official correspondence.