FDA.reportPublic FDA data

PMD

Primary DI
06979826590146
Brand
PMD
Company
Dongguan Hunter Electronic Technology Co., Ltd.
Model
4004-YELLOW-INT
Device description
The pmd clean acne is intended for over-the-counter use to treat mild to moderate inflammatory acne.
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
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
K230490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230490000PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INTDongguan Hunter Electronic Technology Co., Ltd.2023-10-27OLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06979826590146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06979826590146069798265901466979826590146

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
06979826590085PMD4005-twilight-INT2026-02-26
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OLP2026-05-28
18712856075024Silk'nSilkn Beauty Ltd.OLP2026-05-07
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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
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
06979826590191PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590207PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
00858985006360EVRL-OTCERCHONIA CORPORATION, LLCOLP2026-02-09
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06
06978368600108LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06
06978368600160LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06