Accelerating your device certification with comprehensive optical performance data and regulatory documentation.

• Comprehensive Data Readiness: We provide complete datasets required for your FDA 510(k) and CE-MDR submissions, including high-resolution spectral maps, center wavelength stability data, and IV-LI characteristic curves.
• FDA Class I Registration Roadmap: 1ONEVCSEL™ is actively advancing component-level registration. We are on track to complete FDA Class I registration for 90% of our product portfolio by mid-2026, offering you pre-validated building blocks for your medical devices.
• Extended Reliability Testing: All medical-series VCSEL chips undergo rigorous Long-term Aging (HTOL) and ESD sensitivity testing. We provide the raw test reports and MTTF (Mean Time To Failure) calculations to support your system's safety analysis.
• Laser Safety Compliance: We offer detailed integration guides compliant with IEC 60825-1 standards, helping you achieve the correct Eye-Safety classification for your finished handheld beauty or diagnostic products.

Dedicated resources for high-volume OEM/ODM projects and end-to-end system integration.

• Annual Frame Agreement (AFA) Benefits: For high-volume partners with signed annual contracts, we offer BOM-only cost PCBA design. We take on the engineering overhead of circuit layout and driver optimization to minimize your initial R&D investment.
• Full Turnkey Module Integration: Our capabilities extend beyond the chip level. We provide complete ODM services, delivering fully integrated laser modules or finished handheld devices that are factory-tested and ready for your brand’s market entry.
• Technical Dossier Assistance: Our compliance team acts as your external consultant, helping you organize the Technical Files and material safety data needed for global regulatory filings, ensuring a smoother transition from prototype to mass production.
• Flexible NPI & Prototyping: We support the New Product Introduction (NPI) stage with low-volume pilot runs (EVT/DVT). This allows your team to validate designs with production-grade components before committing to large-scale orders.