Direct Access to FDA-Cleared LED Mask Manufacturing
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.
FDA 510(k) Cleared
10993 Tested
13485 Mfg
Certified
RoHS
Compliant
Our Technology
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%.
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).
Competitive Advantage
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
Irradiance
Wavelength Accuracy
Risk Profile
Material Safety
FDA Clearance
True Radiant Skin (Medical Grade)
>30mW/cm²
±5nm Precision
Zero (Hypoallergenic)
ISO 10993 Bio-Silicone
510(k) Class II Medical Device
Cheap Market Alternatives
< 10mW/cm²
Broad Spectrum (Ineffective)
High (Contact Dermatitis Risk)
Industrial Silicone/Plastic (High Risk of Rash)
None / "FDA Registered" only
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.
Launch your private label with as few as 100 units. We support scaling businesses.
We offer silk-screen logo printing, custom controller design, and luxury magnetic packaging.
Production occurs in a Class 100,000 dust-free workshop. Every unit undergoes a 24-hour aging test.
Yes. Our LED mask is FDA 510(k) cleared as a Class II Over-the-Counter (OTC) medical device. We provide the unique 510(k) listing number to our partners for verification with US Customs and Amazon compliance teams.
Yes. Unlike standard silicone masks, our device is manufactured using biocompatible food-grade silicone that has passed ISO 10993 sensitization and irritation testing. It is hypoallergenic and safe for post-procedure recovery.
No additional goggles are strictly necessary due to our design, but we prioritize safety. The mask features built-in medical silicone eye guards that block light from entering the pupil. The device is also IEC/EN 62471 certified for photobiological safety.
For the EU and UK markets, our devices are fully CE Certified and RoHS Compliant (free from hazardous substances). We also adhere to REACH regulations regarding chemical safety in materials.
Yes. We use 100% pure liquid silicone that is BPA-free, Latex-free, and Phthalate-free. This prevents the release of Volatile Organic Compounds (VOCs) when the mask warms up during operation.
We use clinically validated wavelengths with a precision tolerance of ±5nm. Our standard configuration includes Red Light (633nm) for collagen production and Near-Infrared (830nm) for deep tissue repair. Blue Light (415nm) is available for acne treatment.
The True Radiant Skin mask delivers a clinical-grade irradiance of 30mW/cm² to 45mW/cm². This ensures the skin receives the optimal therapeutic dose of energy within a standard 10-minute treatment session.
Yes. Our masks utilize legitimate 830nm or 850nm Near-Infrared chips. This light is invisible to the human eye but penetrates deep into the dermis to reduce inflammation and accelerate healing.
The mask contains 132 LED bulbs housing a total of 280 medical-grade chips (Dual-Chip Technology). This density ensures uniform light coverage across the entire face without "dead zones."
True Radiant Skin devices are manufactured in an ISO 13485 Medical Device facility. They feature higher irradiance (>30mW/cm²), regulated wavelength stability, and biocompatible materials, whereas consumer models often suffer from low power (<10mW/cm²) and unstable light output.
We offer a low barrier to entry. The MOQ for custom logo printing on the device and user manual is just 100 units.
Yes. We offer fully bespoke packaging solutions, including magnetic gift boxes and velvet pouches. The MOQ for fully custom box design is 500 units.
For standard wholesale orders (Generic), the lead time is 3-5 days. For Private Label (OEM) orders involving logo printing, the production time is typically 30 days after artwork approval.
Yes. We strongly encourage ordering a sample kit. Samples are shipped via DHL/FedEx and typically arrive within 5-7 business days. Sample costs are refundable upon placing a bulk order of 100+ units.
We accept T/T (Bank Wire Transfer), PayPal, and Western Union. For OEM production, our standard terms are a 30% deposit to start manufacturing and a 70% balance before shipment.
Yes. Upon becoming a partner, you gain access to our media kit, which includes white-background product photography, lifestyle images, and unbranded video content for your marketing use.