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510(k) Data Aggregation
K Number
K241203Device Name
PMD 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)
Manufacturer
Dongguan Hunter Electronic Technology Co., Ltd.
Date Cleared
2024-07-25
(86 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Hunter Electronic Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K230490Device Name
PMD 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-INT
Manufacturer
Dongguan Hunter Electronic Technology Co., Ltd.
Date Cleared
2023-10-27
(246 days)
Product Code
OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Hunter Electronic Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The pmd clean acne is intended for over-the-counter use to treat mild to moderate inflammatory acne.
Device Description
The pmd clean acne adopts light emitting diodes (LED) in the blue (415nm ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect. The pmd clean acne adopts handheld design, LEDs are contained in the blue light treatment window, and on its reverse side, the soft silicone bristols can be used to clean the face before the blue light treatment. The product is provided with internal battery and it can be charged by external adaptor. To prevent irradiation of LED lights to eyes during the treatment, pmd clean acne is equipped with goggles which blocks light energy from LEDs.
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