FDA.reportPublic FDA data

PMD

Primary DI
06979826590085
Brand
PMD
Company
Dongguan Hunter Electronic Technology Co., Ltd.
Model
4005-twilight-INT
Device description
The PMD Clean Redvolution (All 4005 models) is a hand-held device for over-the counter aesthetic purposes. The red light is intended for the use in treating wrinkles on the face.
Published
2026-02-26
Public version status
Update
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241203000PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)Dongguan Hunter Electronic Technology Co., Ltd.2024-07-25OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06979826590085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06979826590085069798265900856979826590085

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
402793142
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979826590016PMD4005-cream-NA2026-02-26
06979826590023PMD4005-cream-INT2026-02-26
06979826590030PMD4005-moab-NA2026-02-26
06979826590047PMD4005-moab-INT2026-02-26
06979826590054PMD4005-pepper-NA2026-02-26
06979826590061PMD4005-pepper-INT2026-02-26
06979826590078PMD4005-twilight-NA2026-02-26
06979826590092PMD4005-grey-NA2026-02-26
06979826590108PMD4005-grey- INT2026-02-26
06979826590115PMD4004-GREY-NA2026-02-26
06979826590122PMD4004-GREY-INT2026-02-26
06979826590139PMD4004-YELLOW-NA2026-02-26
06979826590146PMD4004-YELLOW-INT2026-02-26
06979826590153PMD4004-PSTO-NA2026-02-26
06979826590160PMD4004-PSTO-INT2026-02-26
06979826590177PMD4004-LPUR-NA2026-02-26
06979826590184PMD4004-LPUR-INT2026-02-26
06979826590191PMD4004-CABLUE-NA2026-02-26
06979826590207PMD4004-CABLUE-NA-INT2026-02-26

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Primary DI, Brand, Company table
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00622356646390Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
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00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OHS2026-05-28
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06980088700013KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
06980088700020KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
18712856075024Silk'nSilkn Beauty Ltd.OHS2026-05-07