FDA.reportPublic FDA data

FAQ 201

Primary DI
07640260120167
Brand
FAQ 201
Company
Foreo AB
Model
Pink Ruby
Device description
FAQ™ 201 is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Published
2024-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240378000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240378000FAQ™ 201, FAQ™ 202Foreo, Inc.2024-04-19OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640260120167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640260120167076402601201677640260120167

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
352394143
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640260120600FAQ LED PanelBlack2026-03-02
07640260120617FAQ Dual LED PanelBlack2026-03-02
07350120791733BEAR 2 eyes & lipsLavender2024-03-07
07350120791740BEAR 2 eyes & lipsArctic Blue2024-03-07
07350120791795BEAR 2Fuchsia2024-03-07
07350120791801BEAR 2Lavender2024-03-07
07350120791818BEAR 2Evergreen2024-03-07
07350120791825BEAR 2 goLavender2024-03-07
07350120791849BEAR 2 goPistachio2024-03-07
07350120791757ESPADA 2 PlusLavender2024-02-20
07350120791764ESPADA 2 PlusPistachio2024-02-20
07640260120662FAQ 202 PlusBlack2025-07-15
07640260120044FAQ 102Pink Ruby2024-07-18
07640260120051FAQ 103Blak Diamond2024-07-18
07640260120112FAQ 102Topaz2024-07-18
07640260120037FAQ 101Amethyst2024-03-01
07350120792976ISSA 4 PlusBlack2025-05-27
07350120792983ISSA 4 PlusLavender2025-05-27
07350120792990ISSA 4Fuchsia2025-05-27
07350120793003ISSA 4Pearl Pink2025-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OHS2026-05-28
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OLP2026-05-28
18712856075024Silk'nSilkn Beauty Ltd.OHS2026-05-07
18712856075024Silk'nSilkn Beauty Ltd.OLP2026-05-07
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.OHS2026-05-03
00850001456791PRO MED BY JOUVALLE Omm Imports Inc.OHS2026-05-02
08056389701115YOUNG AGAINESPANSIONE MARKETING SPAOHS2026-04-30
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOLP2026-04-23
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366030Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
00850523007365CellumaBiophotas, Inc.OHS2026-04-06
00850523007365CellumaBiophotas, Inc.OLP2026-04-06
05060534511231PRIORI Next Generation LED FacemaskI-SMART DEVELOPMENTS LIMITEDOHS2026-03-31
07640260120600FAQ LED PanelForeo ABOLP2026-03-02
07640260120617FAQ Dual LED PanelForeo ABOLP2026-03-02
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOHS2026-02-06
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06
06956822893013SolawaveShenzhen Goodwind technology development Co.,LtdOHS2026-02-04
05060555750756LYMA LaserLYMA LIFE LIMITEDOLP2026-01-28
00811485037210PMDShenzhen Fittop Health Technology Co., Ltd.OLP2026-01-16
06920473100820ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100837ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100844ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100851ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100868ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100875ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100882ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100899ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15