March 27, 2026 — Fotromed Technology Co., Ltd is pleased to announce that our manufacturing facility has successfully passed the ISO 13485 quality management system audit. The certification covers our professional aesthetic device, the Oxygen Revive — a 9-in-1 hydro oxygen facial machine built for medical spas, dermatology clinics, and global distributors.
What Is ISO 13485?
ISO 13485 is the internationally recognized quality management standard designed specifically for medical device manufacturers. It governs every stage of production — from raw material sourcing to final delivery and after-sales support.
Unlike general quality standards, ISO 13485 focuses on areas critical to medical devices:
- 🔍 Risk management and traceability
- 📋 Controlled documentation and process consistency
- 🔧 Corrective action systems for quality deviations
- 📦 Supplier evaluation and incoming material inspection
For buyers and distributors, sourcing from an ISO 13485-certified manufacturer is increasingly a market-entry requirement across the EU, North America, Australia, and beyond. It provides documented assurance that every device is produced under verified, auditable conditions.
Full Certification Scope
The March 27, 2026 audit was broad in scope. Beyond ISO 13485, it evaluated Fotromed against a complete set of IEC 60601 electrical safety and EMC standards applicable to active medical devices.
🛡️ Quality Management ISO 13485 — Medical Devices Quality Management Systems
⚡ Electrical Safety
- IEC 60601-1:2005 + A1:2012 + A2:2020 / EN 60601-1 — General safety and essential performance
- IEC 60601-1 Clause 14 PEMS — Programmable systems and software evaluation
- IEC 60601-2-57:2011 / EN 60601-2-57 — Safety requirements specific to LED medical devices
- IEC 60601-1-9 — Environmentally conscious design
- IEC 60601-1-6 — Usability engineering for medical electrical equipment
📡 Electromagnetic Compatibility (EMC) IEC 60601-1-2:2014 + A1:2020 / EN 60601-1-2 — EMC requirements for professional healthcare environments
This certification stack means the Oxygen Revive is held to the same technical benchmarks as regulated medical electrical equipment — not just cosmetic-grade standards. For distributors handling EU market registration or product due diligence, this documentation provides a solid regulatory foundation.
About the Oxygen Revive
The Oxygen Revive is a professional 9-in-1 clinical workstation that combines three core technologies into one platform:
💡 H2O2 Hydra Dermabrasion — operates at up to 1 bar vacuum pressure for deep pore cleansing and mechanical extraction. This outperforms standard hydrofacial devices, which typically run at 0.4–0.6 bar.
💡 Medical-Grade Oxygen Infusion — powered by a built-in molecular sieve generator delivering ≥95% pure oxygen at 3L/min. Supports deep tissue infusion, bacterial control, and systemic relaxation via the oxygen inhalation mask.
💡 PDT LED Phototherapy — three light spectrums (red, blue, green) for collagen stimulation, acne control, and pigmentation reduction. Fully compliant with IEC 60601-2-57, the dedicated safety standard for LED medical devices.
Additional handles include diamond microdermabrasion, ultrasonic scrubber, BIO microcurrent wand, high-frequency handle, and ultrasonic facial handle — giving practitioners a complete toolkit for addressing a wide range of skin concerns.
The device runs on 110–240VAC, 50/60Hz, making it ready for immediate international deployment.
What This Means for Our Partners
This certification has real, practical value for everyone in our supply chain.
- 📁 Regulatory support — ISO 13485 is a key document for CE marking under EU MDR and is recognized in Canada, Australia, Japan, and more. Distributors can use our certification as part of their own market registration process.
- ✅ Lower sourcing risk — Certified production means controlled processes, documented quality controls, and formal corrective action systems. Fewer surprises, fewer product issues.
- 🏷️ OEM confidence — Custom branding and private label orders are produced under the same certified quality framework. Logo integration is available in as fast as 3–5 business days.
- 💼 Stronger sales conversations — End clients ask harder questions now. Carrying an ISO 13485-certified device gives distributors a clear, documented answer when clinic buyers ask about device safety and manufacturer credentials.
Ready to Partner with Fotromed?
Fotromed’s distribution network now spans across 50+ countries, with established partners across Europe, North America, the Middle East, Southeast Asia, and beyond. Whether you are an equipment distributor, a clinic procurement manager, or an OEM buyer, we are ready to support your growth with certified devices, fast customization, and dedicated after-sales service.
📩 Get in touch at info@fotromed.com or explore the Oxygen Revive to request a quote and full certification documentation.
Fotromed Technology Co., Ltd. — Professional manufacturer and global supplier of medical aesthetic equipment, including HIFU, hydro facial, rf Microneedling, CO₂ laser, Hair Removal, EM body, and PDT LED devices.
