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Found 7 results
510(k) Data Aggregation
K Number
K242747Device Name
FAQ (302)
Manufacturer
Foreo Inc.
Date Cleared
2024-12-11
(90 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Foreo Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FAQ™ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
Device Description
FAQ™ 302 is a handheld rechargeable square shaped device designed for improving hair growth with 20 laser diodes (wavelength 650±10m) and 20 RED LED beads (640-660nm) on the inside surface.
By pressing the universal button, the user can power the device on, start treatment and change the intensity by quick-pressing the button again. Once the treatment is complete, the device is turned off by pressing and holding the universal power button for 3 seconds.
The device can also be connected wirelessly via Bluetooth to an FAQ App in order to manage treatment. After the treatment is completed, the device automatically powers off.
The device uses a non-detachable polymer lithium battery for power supply in compliance with IEC 62133-2:2017+A1:2021 standard.
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K Number
K241102Device Name
Luna 4 plus
Manufacturer
Foreo Inc.
Date Cleared
2024-08-20
(120 days)
Product Code
OHS, NFO
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Foreo Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles
Device Description
Luna 4 plus has multiple functions combined in a single device, like RED+NIR LED Treatment for wrinkle reduction. The device emits visible red/IR light (Red: 630nm +/- 10nm.) for elevating tissue temperature in improving appearance of facial wrinkles. Microcurrent to target facial stimulation. Two microcurrent pins at the back for a targeted toning massage, emitting microcurrent electrical therapy to deliver skin stimulation where maximum power delivered to the load is controlled and limited by integral software. Luna 4 plus is a single device powered by a rechargeable battery. A controller is integrated on the back to control the device, such as turn on/off the device, mode buttons. Rechargeable Li-battery contained in the controller with a USB cable accessible to target it. To user should use the controller to operate.
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K Number
K240616Device Name
FAQ (102)
Manufacturer
Foreo Inc.
Date Cleared
2024-07-15
(132 days)
Product Code
PAY, NFO, 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™ 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.
Device Description
Not Found
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K Number
K232242Device Name
BEAR 2 Body
Manufacturer
FOREO Inc.
Date Cleared
2024-05-13
(290 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 device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
Device Description
Not Found
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K Number
K240378Device Name
FAQ 201, FAQ 202
Manufacturer
Foreo Inc.
Date Cleared
2024-04-19
(72 days)
Product Code
OHS, OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Foreo Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FAO™ 201 and 202 devices are intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Device Description
Not Found
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K Number
K231977Device Name
PEACH 2, PEACH 2 Duo, PEACH 2 go
Manufacturer
Foreo Inc.
Date Cleared
2023-09-25
(84 days)
Product Code
OHT, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Foreo Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PEACH 2, PEACH 2 Duo and PEACH 2 Go are over-the-counter device intended for the removal of unwanted body hair and/or facial hair.
Device Description
Not Found
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K Number
K162450Device Name
ESPADA Acne-Clearing Blue Light Pen
Manufacturer
FOREO INC.
Date Cleared
2016-11-30
(90 days)
Product Code
OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FOREO INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.
Device Description
Not Found
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