FAQ 102

GUDID 07640260120112

FAQ™ 102 devices are over-the-counter home use devices intended for facial and neck skin stimulation, and non-invasive treatments of mild to moderate facial wrinkles for adult women with all skin tones.

Foreo AB

Radio-frequency skin contouring system
Primary Device ID07640260120112
NIH Device Record Keya7aee211-d588-4e6a-b321-24668c388f16
Commercial Distribution StatusIn Commercial Distribution
Brand NameFAQ 102
Version Model NumberTopaz
Company DUNS352394143
Company NameForeo AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS107640260120112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-26
Device Publish Date2024-07-18

On-Brand Devices [FAQ 102]

07640260120112FAQ™ 102 devices are over-the-counter home use devices intended for facial and neck skin stimu
07640260120051FAQ™ 103 devices are over-the-counter home use devices intended for facial and neck skin stimu
07640260120044FAQ™ 102 devices are over-the-counter home use devices intended for facial and neck skin stimu

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