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Regulatory Compliance
Our Neurolase™ systems comply with the following Regulations and Standards:
• 21 CFR 1010: Performance Standards for Electronic Products
• 21 CFR 1040: Performance Standards for Light Emitting Products
• IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety
• IEC 60601-2-22: Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment
• IEC 60825-1: Safety of Laser Products, Equipment Classification, Requirements, and User's Guide
• CISPR 11:2004: Electromagnetic Compatibility
• FCC Part 18: Electromagnetic Emissions
Our training program and materials were developed to meet the recommendations of:
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