FDA laser registration

Product introduction： Laser certification1. Application FormApplication form: including company information, product information, etc2. Product File / Technology SpecificationProduct documents / technical data: mainly including the preparation of detailed instructions / sales manuals, installation manuals, maintenance manuals, etc; Product assembly drawing; And product technical information, whether there are laser protection measures and their working principle description.3. LabelLabels: English labels that comply with the regulations, including warning labels with warning signs, product labels, compliance certification labels (such as complies with 21 CFR 1040.10 & 1040.11), and light outlet labels, etc.4. Laser InformationLaser device information: type of laser generator, medium, laser optical path diagram, laser parameters, laser device certificate / test records (if purchased from other manufacturers, the manufacturer's information, laser device parameters / datasheet or instructions, and whether the laser device has FDA certification / if any, FDA number shall be provided).5. Calibration Report of Power MeterAnnual metrological verification certificate and report of optical power meter.6. Quality Control SystemQuality control documents: mainly include internal quality control flow chart, inspection procedures, quality control specifications / such as control of design modification; Production line sampling table, incoming material inspection sheet, finished product inspection sheet, internal inspection report, etc. (including samples of the table).7. US Agent / ImporterInformation of U.S. agent and U.S. importer: including contact person's full name, telephone / fax / email, U.S. detailed address / postal code and company name; And U.S. agent principal-agent authorization agreement.Application processEnterprise registrationEnterprise registration application formFDA confirms and issues the enterprise serial number;1.2. Product registration1 medical device products are divided into three categories according to the degree of safety risk:a) Class 1 medical device listing controlCategory 2 market access Accreditation (i.e. 510 (k) accreditation)c) Approval of Category 3 PMA before entering the market1.2.2 entrusted agentFDA registration and notification entrustment agreement (signed by the legal representative and stamped with the company's official seal)Provision of informationBusiness license of enterprise legal personCode certificate of public institution legal person, registration certificate of association legal person, etc. (copy with official seal of the company)a) Qualification certificate or production license certificate within the validity period (copy stamped with the company's official seal)b) FDA registration application form (one in Chinese and one in English, stamped with the company's official seal)c) Other documents required to be submitted by FDA (if any).Company profile (establishment time, economic performance, technical strength, main production varieties and their performance, asset status).1.3 paymentRegistration and listing are free;510 (k) and PMA shall be paid according to the charging standard published by FDA online.RegisterAfter charging, fda60 working days to complete the registration;The FDA website will announce the registration information, and the FDA of 510 (k) and PMA will send another approval letter.

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Certification application

Laser certification

1. Application Form
Application form: including company information, product information, etc

2. Product File / Technology Specification
Product documents / technical data: mainly including the preparation of detailed instructions / sales manuals, installation manuals, maintenance manuals, etc; Product assembly drawing; And product technical information, whether there are laser protection measures and their working principle description.

3. Label
Labels: English labels that comply with the regulations, including warning labels with warning signs, product labels, compliance certification labels (such as complies with 21 CFR 1040.10 & 1040.11), and light outlet labels, etc.

4. Laser Information
Laser device information: type of laser generator, medium, laser optical path diagram, laser parameters, laser device certificate / test records (if purchased from other manufacturers, the manufacturer's information, laser device parameters / datasheet or instructions, and whether the laser device has FDA certification / if any, FDA number shall be provided).

5. Calibration Report of Power Meter
Annual metrological verification certificate and report of optical power meter.

6. Quality Control System
Quality control documents: mainly include internal quality control flow chart, inspection procedures, quality control specifications / such as control of design modification; Production line sampling table, incoming material inspection sheet, finished product inspection sheet, internal inspection report, etc. (including samples of the table).

7. US Agent / Importer
Information of U.S. agent and U.S. importer: including contact person's full name, telephone / fax / email, U.S. detailed address / postal code and company name; And U.S. agent principal-agent authorization agreement.

Application process
Enterprise registration
Enterprise registration application form
FDA confirms and issues the enterprise serial number;
1.2. Product registration

1 medical device products are divided into three categories according to the degree of safety risk:

a) Class 1 medical device listing control

Category 2 market access Accreditation (i.e. 510 (k) accreditation)

c) Approval of Category 3 PMA before entering the market

1.2.2 entrusted agent

FDA registration and notification entrustment agreement (signed by the legal representative and stamped with the company's official seal)

Provision of information

Business license of enterprise legal person

Code certificate of public institution legal person, registration certificate of association legal person, etc. (copy with official seal of the company)

a) Qualification certificate or production license certificate within the validity period (copy stamped with the company's official seal)
b) FDA registration application form (one in Chinese and one in English, stamped with the company's official seal)
c) Other documents required to be submitted by FDA (if any).

Company profile (establishment time, economic performance, technical strength, main production varieties and their performance, asset status).

1.3 payment

Registration and listing are free;

510 (k) and PMA shall be paid according to the charging standard published by FDA online.

Register

After charging, fda60 working days to complete the registration;

The FDA website will announce the registration information, and the FDA of 510 (k) and PMA will send another approval letter.

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