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  laser product doucments

Laser products FDA registration
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1. Application Form
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Fill in the application form: contains company information, product information and so on
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2. Product File / Technology Specification
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Product documentation / technical information: including the preparation of detailed instructions / sales manual, installation manual, maintenance manual, etc .; product assembly drawings; and product technical information, with or without laser protection measures and their working principle description.
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3. Label
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Label: Eligible English label, warning label with warning sign, product label, conformity certification label (eg Complies with 21 CFR 1040.10 & 1040.11), and exit mark label and so on.
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4. Laser Information
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Laser device information: laser generator type, medium, laser light path, laser parameters, laser device certificate / test record (if purchased from other manufacturers, need to provide the manufacturer's information, laser device parameters / Datasheet or instructions, and the Laser devices with or without FDA certification / need to provide the FDA number).
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5. Calibration Report of Power Meter
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Optical power meter annual measurement test certificate and report.
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6. Quality Control System
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Quality control documents: Mainly include internal quality control flow chart, inspection procedures, quality control specifications / such as design and control aspects of control; production line sampling table, incoming inspection single, finished product inspection, internal inspection reports (including table samples) The
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7. US Agent / Importer
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US agent and US importer information: including contact full name, telephone / fax / email, US address / zip code, company name;

More questions are welcome to contact
US FDA Registration Advisory Line: 15602970173 QQ: 2695669655

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