Compliance & Quality Assurance
We hold the highest international medical and electrical certifications, ensuring that our partners can distribute our products in any major global market with absolute legal confidence.
FDA 510(k) Cleared
Facility Registration No: 3012XXXX. Essential for legal distribution in the Professional US Medical & Aesthetic market.
Medical CE (Europe)
Fully compliant with European Union safety, health, and environmental protection requirements for LED therapy.
ISO Factory Standard
Our factory operates under the strict ISO 13485:2016 quality management system for medical device manufacturers.
FCC (North America)
Ensures zero electromagnetic interference and compatibility with North American electrical grids.
RoHS (Europe)
Verification of hazardous substance restriction. 100% lead-free and eco-friendly manufacturing.
SAA (Australia)
Certified for the Australian and New Zealand markets, including specific plug and voltage safety.
Quality Control Standards
AQL 0.4 Acceptance Level
Unlike consumer factories that use AQL 1.5, we implement a strict 0.4 Acceptance Quality Limit. This means any batch with even minor defects is immediately rejected and re-audited.
Spectrometer Batch Verification
Every manufacturing run undergoes a 12-checkpoint optical audit to ensure that the NM (Nanometer) variance is within ±2nm of the clinical target.
Verify Our Credentials
We provide full, un-redacted PDF copies of our certificates and lab reports for due diligence purposes during the procurement process.