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 →How Buyers Should Verify Scope
A certificate or listing is only useful when it matches the exact model, intended use, and destination market. Use this sequence before relying on any compliance claim.
- 1. Identify the SKU
Record model number, configuration, and intended claims language. - 2. Name the market
U.S., EU, Australia, and other destinations require different document sets. - 3. Request the pack
Ask for holder, scope, issue/expiry dates, and model-to-document mapping. - 4. Cross-check public databases
Where applicable, verify FDA records or certificate details against official sources.
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We do not publish certificate numbers on this page because coverage is model- and market-specific.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 |
Compliance Pack Evidence Gate
This page does not publish certificate numbers until a SKU-level pack has been approved for release. That keeps the buyer-facing claim limited to what can actually be verified: exact holder, scope, issue or expiry date, and model-to-document mapping.
- 1. RequestSend SKU, target market, intended use, and document scope.
- 2. Internal reviewQuality maps holder, scope, dates, and covered models.
- 3. Owner approvalApprove the controlled release and log it in the evidence manifest.
- 4. DeliverySend the pack through the same channel as the SKU quotation.
Use the import and verification checklist to prepare the exact information a compliance pack should cover.
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.
Compliance Documentation FAQ
Does this page certify all red light therapy products?
No. Compliance is model- and market-specific. Buyers should request the exact SKU, legal manufacturer, certificate scope, issue or expiry date, and model-to-document mapping before relying on any compliance claim.
What compliance documents should buyers request?
Buyers should request the certificate holder, covered activities or models, issuing body, report or certificate number, dates, scope, and any destination-market restrictions for the exact SKU.
How can buyers verify official compliance records?
Request the model-to-document mapping from Hello Red Light, then cross-check public databases or issuing bodies where applicable before finalizing the order.
What documents are required for a commercial red light therapy bed?
Request the exact SKU mapping for FDA records, CE/MDR conformity records, RoHS/FCC reports, the certificate holder, issuing body, scope, issue/expiry dates, and destination-market import documentation before ordering.
Verify Our Credentials
We provide model-specific certificate and report packs for due diligence during procurement, with holder, scope, dates, and covered SKUs mapped to your request.