FDA Laser Registration
Laser certification1. Application FormApplication form: including company information, product information, etc2. Product File/Technology SpecificationProduct documents/technical materials: mainly including preparing detailed manuals/sales manuals, installation manuals, maintenance manuals, etc; Product assembly drawings; And product technical information, whether there are laser protection measures and a description of their working principles.3. LabelLabels: English labels that comply with regulations, including warning labels, product labels, compliance certification labels (such as Complaints with 21 CFR 1040.10&1040.11), and exit labeling labels, etc.4. Laser InformationLaser device information: Type of laser generator, medium, laser path diagram, laser parameters, laser device qualification certificate/test record (if purchased from other manufacturers, information of the manufacturer, laser device parameters/datasheet or manual, and whether the laser device has FDA certifica...
2017
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06
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28