1. Application Form:
Application form: contains company information, product information, etc
2. Product File/Technology Specification:
Product documents/technical data: mainly including the preparation of detailed manuals/sales manuals, installation manuals, maintenance manuals, etc. Product assembly drawing; And product technical information, laser protection measures and working principle description.
3. The Label:
Labels: English labels for compliance, warning labels with warning labels, product labels, conformity certification labels (such as Complies with 21 CFR 1040.10&1040.11), and light outlet labels, etc.
4. The Laser Information:
Laser device information: laser generator type, medium, laser path diagram, laser parameters, laser device certificate/test record (if purchased from other manufacturers, it is required to provide the manufacturer's information, laser device parameters /Datasheet or instructions, and whether the laser device is FDA certified/FDA number if it is available).
Calibration Report of Power Meter
Annual metrological verification certificate and report of optical power meter.
6. Quality Control System
Quality control documents: mainly including internal quality control flow chart, inspection procedures, quality control specifications/such as design modification control; Production line sampling sheet, incoming material inspection sheet, finished product inspection sheet, internal inspection report, etc. (including the sample of the form).
7. US Agent/Importer:
Us agent and US importer information: including contact person's full name, phone/fax/email, US address/zip code, company name; And the U.S. Agent authorization Agreement.
