M01 LED Light Therapy Mask

$190.00

Wholesale Face Mask Devices platform for private-label and distribution programs.

Unit price: US$190.00
MOQ: 100 units · OEM / ODM customization available

Built for a clearer private-label brief.

A flexible, full-face light therapy platform for brand programs that need model-specific FDA 510(k) documentation.

240 LEDs
4 light-source groups
3 intensity levels
5 W
3.7 V / 3000 mAh controller

Regulatory status, kept model-specific.

FDA 510(k) cleared under K251667. Clearance applies to M01 only within this product record.

Documentation availability does not automatically transfer to a changed enclosure, electronics package, accessory set or market claim. We review the final configuration before confirmation.

Turn the platform into your product.

Discuss colour, logo treatment, packaging, accessories, controller presentation and market documentation with our project team.

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The M01 is a flexible full-face silicone mask built on a 240-LED, four-wavelength platform (415 / 605 / 630 / 850 nm) with a 3000 mAh controller — available in black or white for private-label programs.

Specifications

Model	M01
Material	Medical-grade liquid silicone
LED count	240 LEDs, 46 mW/cm² energy density
Wavelengths	415 nm blue · 605 nm orange · 630 nm red · 850 nm near-infrared
Power / voltage	5 W / 3.7 V
Battery	3000 mAh
Charging time	≈ 4 h
Use time	≈ 2 h
Retail box	34 × 22.7 × 4.6 cm, 0.93 kg
Carton	16 pcs / 41 × 35 × 50 cm / 15.72 kg
Package	Mask, controller, charging cable, manual, fixing strap

M01 LED Light Therapy Mask detail page 1

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Model documentation

Evidence for this model.

Open the supplied certificates, test reports and supporting transport documents associated with this product family.

FDA 510(k) Face Mask - 1.2 m Drop Test Report - CMC251031064D01 document preview

Source PDFFDA 510(k) Face Mask – 1.2 m Drop Test Report – CMC251031064D01Open document ↗

FDA 510(k) Face Mask - Air Transport Report document preview

Source PDFFDA 510(k) Face Mask – Air Transport ReportOpen document ↗

FDA 510(k) Face Mask - Battery Safety Data Sheet - CMC251031064M01 document preview

Source PDFFDA 510(k) Face Mask – Battery Safety Data Sheet – CMC251031064M01Open document ↗

FDA 510(k) Face Mask - Battery Test Summary document preview

Source PDFFDA 510(k) Face Mask – Battery Test SummaryOpen document ↗

FDA 510(k) Face Mask - FDA 510(k) Decision Letter - K251667 document preview

Source PDFFDA 510(k) Face Mask – FDA 510(k) Decision Letter – K251667Open document ↗

FDA 510(k) Face Mask - FDA 510(k) Summary - K251667 document preview

Source PDFFDA 510(k) Face Mask – FDA 510(k) Summary – K251667Open document ↗

FDA 510(k) Face Mask - Sea Transport Report document preview

Source PDFFDA 510(k) Face Mask – Sea Transport ReportOpen document ↗

FDA 510(k) Face Mask - Stacking Test Report - CMC251031064S01 document preview

Source PDFFDA 510(k) Face Mask – Stacking Test Report – CMC251031064S01Open document ↗

FDA 510(k) Face Mask - UN 38.3 Battery Transport Test - CMC251031064 document preview

Source PDFFDA 510(k) Face Mask – UN 38.3 Battery Transport Test – CMC251031064Open document ↗

Scope note: FDA 510(k) K251667 explicitly lists models M01, M02, M06, M07, M08 and M09. The accompanying transport documents cover the 18650 3000mAh configuration shown for this model family.