Compliance & Quality Assurance
Compliance is model- and market-specific. We provide buyers with the applicable test reports, certificates, and regulatory records for the exact SKU and destination market before an order is finalized.
U.S. FDA Documentation
Model-specific 510(k), listing, and establishment records
A 510(k) clearance applies to a specific device. Request the exact clearance number and verify the legal manufacturer and model in the FDA database before purchase.
Request Compliance Pack →EU CE / MDR Documentation
Model-specific classification and conformity records
Request the declaration of conformity, certificate scope, legal manufacturer, intended use, and notified-body details applicable to the exact model.
Request Compliance Pack →ISO 13485:2016
Quality-system records for buyer verification
Request the certificate holder, covered activities, issuing body, certificate number, and current expiry date before relying on the claim.
Request Compliance Pack →FCC Part 15B
EMC report review for applicable models
Request the covered SKU, lab, test date, and report number before relying on FCC documentation for a market-entry decision.
Request Compliance Pack →RoHS (Directive 2011/65/EU)
Hazardous substance documentation by SKU
Request material composition reports and the exact covered model list before relying on RoHS documentation.
Request Compliance Pack →SAA (Australia)
Regional safety documentation review
For Australia and New Zealand, request the plug, voltage, standard, certificate holder, and model coverage before purchase.
Request Compliance Pack →SKU Documentation Matrix
We do not publish certificate numbers on this page because coverage is model- and market-specific. Qualified buyers receive the exact pack for the SKU and destination under review.
| SKU | Product | Spec PDF | Compliance pack |
|---|---|---|---|
| HRL-PRO-1500 | Pro 1500W Panel | Download | Available on request |
| HRL-PRO-300 | Pro 300W Mini Panel | Download | Available on request |
| HRL-MASK-SILICONE | Silicone LED Mask | Download | Available on request |
| HRL-LUXOR-360 | Luxor 360 Bed | Download | Available on request |
| HRL-TORCH | Cold Laser Pen | Download | Available on request |
| HRL-BELT | Therapy Belt | Download | Available on request |
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.