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Found 2 results
510(k) Data Aggregation
K Number
K222012Device Name
FAQ 101
Manufacturer
Foreo, Inc.
Date Cleared
2023-04-05
(271 days)
Product Code
PAY, OHS
Regulation Number
878.4420Why did this record match?
Applicant Name (Manufacturer) :
Foreo, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FAQ™ 101 devices are over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.
Device Description
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K Number
K200803Device Name
BEAR and BEAR mini
Manufacturer
FOREO, Inc.
Date Cleared
2020-07-31
(126 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
FOREO, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BEAR and BEAR mini devices are intended for facial and neck stimulation and are indicated for over-the-counter cosmetic use.
Device Description
Not Found
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