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Direct Access to FDA-Cleared LED Mask Manufacturing

FDA-Cleared LED Mask Manufacturer & Wholesale Solutions.

The Safest Professional Choice for Spas & Dermatologists.

Eliminate the risk of contact dermatitis and skin irritation. True Radiant Skin supplies the world’s only clinical-grade LED masks using ISO 10993 biocompatible silicone. We offer factory-direct pricing, FDA 510(k) clearance, and low-MOQ private label solutions for premium beauty brands.

Certified for Global Medical & Aesthetic Markets

FDA

FDA 510(k) Cleared

ISO

10993 Tested

ISO

13485 Mfg

CE

Certified

RoHS

Compliant

Our Technology

Medical-Grade Technology & Biocompatible Safety

1. Precision Wavelengths & Power (The Efficacy)

Our masks utilize medical-grade chips with strict tolerances to ensure consistent clinical outcomes. We deliver an irradiance of >30mW/cm², ensuring adequate energy absorption within a 10-minute treatment window—outperforming standard consumer masks by 300%.

  • Red Light (633nm ±5nm): Stimulates collagen & elastin.

  • Near-Infrared (830nm ±5nm): Deep tissue repair & inflammation reduction.

  • Blue Light (415nm ±5nm): Targets acne-causing bacteria.

2. Hypoallergenic "Bio-Silicone" (The Safety)

Stop risking contact dermatitis. Cheap masks use industrial silicone that releases VOCs when heated. True Radiant Skin masks are molded from platinum-cured, medical-grade silicone that has passed ISO 10993 Biocompatibility Testing (Sensitization & Irritation).

  • Patient Safe: Ideal for use immediately after microneedling or peels.

  • Non-Toxic Purity: 0% Latex, 0% BPA, 0% Phthalates.

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Competitive Advantage

Why Top Spas Choose True Radiant Skin Over Cheap Alternatives

In the professional aesthetics market, liability is a major concern. Many low-cost LED masks flooding the market utilize industrial-grade plastics and unstable power supplies. These can lead to "contact dermatitis," thermal burns, and ineffective treatments. True Radiant Skin protects your brand reputation by adhering to strict medical device standards.

Feature
True Radiant Skin (Medical Grade)
Cheap Market Alternatives
Irradiance
>30mW/cm²
< 10mW/cm²
Wavelength Accuracy
±5nm Precision
Broad Spectrum (Ineffective)
Risk Profile
Zero (Hypoallergenic)
High (Contact Dermatitis Risk)
Material Safety
ISO 10993 Bio-Silicone
Industrial Silicone/Plastic (High Risk of Rash)
FDA Clearance
510(k) Class II Medical Device
None / "FDA Registered" only

Manufacturing

Your Direct Access to Medical-Grade Manufacturing

True Radiant Skin is your strategic partner for medical-grade manufacturing. We provide global brands with direct access to ISO 13485 certified production lines, eliminating the middleman. By partnering with us, you get the pricing and customization power of a manufacturer, with the service and logistics reliability of a global supplier.

01

Low MOQ for Startups

Launch your private label with as few as 100 units. We support scaling businesses.

02

Custom Branding

We offer silk-screen logo printing, custom controller design, and luxury magnetic packaging.

03

Medical-Grade QC

Production occurs in a Class 100,000 dust-free workshop. Every unit undergoes a 24-hour aging test.

Frequently asked questions

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