FDA.reportPublic FDA data

Neutrogena

Primary DI
00070501101261
Brand
Neutrogena
Company
Kenvue Brands LLC
Model
00070501101261
Device description
Light Therapy Acne Mask Activator
Published
2016-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLPOver-the-counter powered light based laser for acne

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123999000ILLUMASK ACNE LIGHT THERAPY MASKLa Lumiere, LLC2013-08-28OLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00070501101261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00070501101261000705011012610705011012610070501101261

GMDN Terms#

Term, Definition table
TermDefinition
Red/blue light phototherapy unitA portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure0.7 KiloPascal1.06 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)361-8068xxx@xxx.com

Regulatory Flags#

DUNS number
118772437
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00300450141019ZYRTEC003004501410192026-05-29
00300450141026ZYRTEC003004501410262026-05-29
00312547202282Listerine003125472022822025-01-01
00312547202299Listerine003125472022992025-01-01
00312547235952Listerine003125472359522017-12-10
00312547235976Listerine003125472359762017-12-10
00381372020453Johnson & Johnson First Aid003813720204532022-01-31
00381372020118Johnson & Johnson First Aid003813720201182021-08-16
00381372020682Johnson & Johnson Red Cross003813720206822021-07-30
00381371192533BAND-AID Brand Adhesive Bandages003813711925332021-02-01
00381371194827Johnson & Johnson First Aid003813711948272020-04-06
00070501101247Neutrogena000705011012472016-09-30
00070501101315Neutrogena000705011013152017-07-08
00070501260364Neutrogena000705012603642017-08-11
00070501260395Neutrogena000705012603952017-08-11
00070501302743Neutrogena000705013027432017-08-11
00074300012537Visine000743000125372016-09-05
00312547235969Listerine003125472359692017-12-10
00381370055679BAND-AID Brand Adhesive Bandages003813700556792018-09-12
00381370055709BAND-AID Brand Adhesive Bandages003813700557092018-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00622356646390Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OLP2026-05-28
18712856075024Silk'nSilkn Beauty Ltd.OLP2026-05-07
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOLP2026-04-23
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990198NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990204NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990211NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990228NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990334NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06978368600221DreameShenzhen Rainbow Technology Co.,LtdOLP2026-04-07
06978368600238DreameShenzhen Rainbow Technology Co.,LtdOLP2026-04-07
06978368600245DreameShenzhen Rainbow Technology Co.,LtdOLP2026-04-07
00850523007365CellumaBiophotas, Inc.OLP2026-04-06
06974667829110UlikeShenzhen Ulike Smart Electronics Co., Ltd.OLP2026-03-26
07640260120600FAQ LED PanelForeo ABOLP2026-03-02
07640260120617FAQ Dual LED PanelForeo ABOLP2026-03-02
06979826590115PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590122PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590139PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590146PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590153PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590160PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590177PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590184PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26