In the competitive LED beauty device market, compliance is no longer optional — it’s the foundation of sustainable growth.
If you’re launching or scaling a red light therapy brand in the U.S., EU, or other regulated markets, your products must be engineered with FDA documentation readiness, CE certification, and FCC compliance in mind.
Our LED mask portfolio — including G13, G15, and G17 — is engineered with FDA documentation support, CE certification, and FCC compliance in mind, helping partners enter regulated markets with confidence.
Why FDA Documentation Support Matters
The U.S. FDA regulates LED light therapy devices under medical device frameworks. While many at-home masks are sold online, not all manufacturers can provide:
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Technical construction files
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CEM & electrical safety reports
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Irradiance verification data
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Risk analysis documentation
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Labeling compliance guidance
Working with a compliance-ready manufacturer protects:
✔ Customs clearance
✔ Retail approval
✔ Platform compliance reviews
✔ Long-term brand credibility
Compliance-Ready Models
Below are three regulatory-focused models designed for different market positioning strategies.
1️⃣ G13 Silicone LED Face Mask
Flexible. Scalable. Compliance-Prepared.
Ideal for: E-commerce brands & private label programs
Compliance Highlights
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FDA technical documentation support
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CE & FCC certified
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Medical-grade silicone validation
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Battery safety protection system
Technical Specifications
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Longitudes de onda: 630Nuevo Méjico / 850Nuevo Méjico
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irradiancia: 30–35 mW/cm²
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Lightweight full-face silicone structure
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USB-C charging
The G13 is engineered for daily-use collagen stimulation while maintaining documentation readiness for regulated markets.
2️⃣ G15 Advanced LED Therapy Mask
Multi-Mode Structured Performance Device
Ideal for: Premium retail & distributor expansion
Compliance Highlights
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FDA registration preparation assistance
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CE / FCC certification
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Controlled wavelength calibration
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Electrical & thermal safety testing
Technical Specifications
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Longitudes de onda: 415Nuevo Méjico / 630Nuevo Méjico / 850Nuevo Méjico
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irradiancia: 35–50 mW/cm²
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Structured ABS facial contour design
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Multi-program treatment modes
G15 delivers both acne and anti-aging functionality within verified irradiance standards suitable for professional positioning.
3️⃣ G17 Professional Multi-Spectrum LED Mask
High-Performance. Deep Penetration. Regulatory Ready.
Ideal for: Medical aesthetic & clinic-grade distribution
Compliance Highlights
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FDA documentation support
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CE & FCC approved
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Risk assessment & technical file assistance
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Advanced heat management system
Technical Specifications
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Longitudes de onda: 630Nuevo Méjico / 830Nuevo Méjico / 1072Nuevo Méjico
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irradiancia: 40–55 mW/cm²
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Reinforced structural shell
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Even full-face LED distribution
The inclusion of 1072nm near-infrared allows deeper dermal penetration while maintaining calibrated energy output for safety compliance.
Compliance Comparison Overview
| Modelo | FDA Documentation Support | CE | FCC | irradiancia | Material | Market Position |
|---|---|---|---|---|---|---|
| G13 | ✔ | ✔ | ✔ | 30–35 mW/cm² | Medical silicone | DTC scalable |
| G15 | ✔ | ✔ | ✔ | 35–50 mW/cm² | Reinforced ABS | Premium retail |
| G17 | ✔ | ✔ | ✔ | 40–55 mW/cm² | Structural shell | Clinic-grade |
Engineering Standards Behind Compliance
All three models are built with:
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Stable wavelength calibration control
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Verified power density testing
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Overheat & short-circuit protection
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LED bin consistency management
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Battery overcharge & voltage protection
These structural controls support:
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A NOSOTROS. FDA listing preparation
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Amazon & retail compliance verification
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International distributor audits
OEM & Regulatory Support for B2B Partners
We provide qualified partners with:
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Technical specification sheets
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Compliance labeling guidance
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Regulatory document preparation support
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Long-term product lifecycle coordination
Our goal is to help brands build LED therapy lines that are:
✔ Scientifically positioned
✔ Electrically safe
✔ Regulatory-prepared
✔ Market scalable
Build with Compliance from Day One
In regulated markets, compliance is infrastructure — not an afterthought.
Choose a partner that understands:
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Wavelength science
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Irradiance calibration
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Medical-grade materials
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International regulatory frameworks
Contact us today to request FDA documentation support and wholesale pricing for G13, G15, and G17 models.
