| 1. Wavelength options | Red-light masks commonly specify wavelengths in the approximate 630–660 nm range. Some models add near-infrared LEDs, often specified around 810–850 nm. Exact output depends on the product design. | LED sourcing, wavelength-bin control, circuit design, and consistency between production batches. | Model-specific spectral test report, LED specifications, and batch inspection records. |
| 2. Irradiance and dose reporting | Irradiance and treatment dose are product-specific. A meaningful comparison requires the measurement distance, test method, units, and treatment duration—not just an LED count. | Ability to measure optical output on finished masks and maintain documented calibration procedures. | Finished-product irradiance map, measurement conditions, and dose calculation for the recommended session. |
| 3. LED layout and coverage | Mask designs vary in LED quantity, spacing, and coverage of areas such as the forehead, cheeks, nose, and chin. More LEDs alone do not establish more uniform exposure. | Optical and mechanical design capability, including repeatable LED placement and coverage testing. | LED layout drawing, coverage map, and test results across the intended treatment area. |
| 4. Treatment controls | Common design features include timed sessions, preset modes, and adjustable intensity. Available modes and settings differ by model. | Controller assembly, firmware version control, timer verification, and functional testing. | User manual, control-function test procedure, and sample production inspection checklist. |
| 5. Fit and materials | Flexible masks may use silicone or other polymer materials; fit, weight, eye-area design, and cleaning instructions are model-dependent. | Material traceability, molding or forming control, dimensional inspection, and assembly consistency. | Material specifications, dimensional drawings, cleaning guidance, and applicable material test reports. |
| 6. Electrical and optical safety | Safety assessment should match the product’s intended use and markets. IEC 60601-1, IEC 60601-1-2, and IEC 62471 are standards buyers may ask suppliers to assess for applicability; listing a standard does not prove compliance. | Design-risk review, electrical testing access, EMC pre-compliance capability, and corrective-action processes. | Current test reports for the exact model, issuing laboratory details, and applicable declarations or certificates. |
| 7. Quality management | Quality-system credentials should be checked for scope, issuing body, validity, and whether the certified site and activities cover the product. | Document control, incoming inspection, in-process checks, final inspection, complaint handling, and traceability. | Quality-system certificate and scope, audit information, sample inspection records, and lot-traceability example. |
| 8. Production and capacity | Capacity, lead time, minimum order quantity, and customization options vary by factory, model, and component availability. | In-house versus outsourced processes, line capacity, production scheduling, and contingency planning for key components. | Factory profile, process flow, stated capacity with assumptions, and a production schedule for a sample order. |
| 9. Verification and quality control | Useful controls include checks for LED operation, controller functions, charging or power performance, appearance, and packaging. | Written acceptance criteria, calibrated equipment, defect handling, and inspection records tied to production lots. | Quality-control plan, sample final inspection report, and documented procedures for nonconforming products. |
| 10. Customization and export readiness | Private-label packaging, manuals, accessories, and product configuration may be available, subject to validation and order requirements. | Artwork and revision control, packaging checks, export documentation support, and change-management procedures. | Customization specification, approved sample process, packaging documents, and a list of changes requiring re-testing. |