FDA.reportPublic FDA data

Luna 4 Plus

Primary DI
07350120791245
Brand
Luna 4 Plus
Company
Foreo AB
Model
Pink
Device description
Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED light & Microcurrent MassageMicrocurrent: indicated for facial stimulationRED+IR: indicated for treat periorbital wrinkle
Published
2024-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241102000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241102000Luna 4 plusForeo, Inc.2024-08-20OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350120791245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350120791245073501207912457350120791245

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

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