FDA.reportPublic FDA data

FAQ 411

Primary DI
07640260120464
Brand
FAQ 411
Company
Foreo AB
Model
Black
Device description
FAQ 411 is intended to use microcurrent for body stimulation, and to use red LED light as a noninvasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs.
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes
OLIFat Reducing Low Level Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2
OLIFat Reducing Low Level LaserGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261565000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261565000FAQ™ (FAQ 411)Foreo, Inc.2026-10-22NFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640260120464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640260120464076402601204647640260120464

Regulatory Flags#

DUNS number
352394143
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640260120501FAQ 401Dark Purple2026-11-05
07640260120518FAQ 402Black2026-11-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640260120501FAQ 401Foreo ABNFO2026-11-05
07640260120518FAQ 402Foreo ABNFO2026-11-05
00855264008695CamarAura MedicalNFO2026-10-22
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDNFO2026-10-12
00851530007263AvazziaAVAZZIA INCNFO2026-09-18
00851530007270AvazziaAVAZZIA INCNFO2026-09-18
00858985006391Erchonia CLXERCHONIA CORPORATION, LLCOLI2026-07-21
06973337180018Led Light Phototherapy BedShenzhen Suyzeko LimitedOLI2026-05-09
06973337180025Led Light Phototherapy BedShenzhen Suyzeko LimitedOLI2026-05-09
00851367006224ZIIP BeautyZIIP, INC.NFO2026-04-22
00851530007621AvazziaAVAZZIA INCNFO2026-04-21
00851530007638AvazziaAVAZZIA INCNFO2026-04-21
06977168990013NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990150NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990273NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
00850021950088Medi Lift YA-MAN LTD.NFO2026-02-19
00810075943276NuFACENufaceNFO2026-01-27
00810075944570NuFACENufaceNFO2026-01-27
00850021950071Medi Lift YA-MAN LTD.NFO2026-01-14
06979082450000FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450017FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450024FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
00851367006217ZIIP BeautyZIIP, INC.NFO2025-09-30
05391540830871Préime DermaFacial EMA AESTHETICS LIMITEDNFO2025-09-15
00851367006163ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006170ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006187ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006194ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006200ZIIP BeautyZIIP, INC.NFO2025-08-07