FDA registration of laser products-ECMG Electronic Technical Testing Corp.(shenzhen)

FDA registration of laser products

2021-04-08

According to the regulations of the US FDA, laser products are classified into four hazard levels to distinguish and manage the risks they pose.

I. Classification of Hazard Levels for Laser Products

Class FDA	Class IEC	激光危害	Product Examples
I	1, 1M	被认为是无害的。如果使用光学辅助设备（包括放大镜、双筒望远镜或望远镜）观看，危险会增加。	激光打印机 CD播放机 DVD播放机
IIa, II	2, 2M	长时间直接观看，危险会增加	条形码扫描仪
IIIa	3R	直接观察或以肉眼直视光束时可能会暂时造成危险	激光笔
IIIb	3B	直射光束会立即对皮肤造成危害，直接观看时会直接对眼睛造成危害。	激光表演放映机工业激光器
IV	4	暴露于直射光束或反射光束会直接造成皮肤和眼睛危害；还可能引起火灾。	激光表演放映机工业激光器用于眼科手术或皮肤治疗的医疗设备激光器

According to different risk levels, submit the following information materials to fulfill the FDA registration requirements.

1. Basic Information

2. Products and Models

3. Label

4. Product information, service manual

5. Detailed Product Description

6. Laser Level

7. Performance Compliance Requirements

8. Compliance Testing

9. Service Life

10. Calibration

Adaptation of the product:

Audio, video and computer equipment components, such as CDs, DVDs, Blu-ray, HD (High Definition) or other optical disc players and recorders

2. Barcode reader

3. Printers, copiers, fax machines

4. Laser pointer for demonstration, measurement and positioning

5. Fiber optic systems used for telephones, video, and computer networks.

6. For material processing operations, such as laser cutting machines, laser welding machines, laser engraving, etc.

7. Used in laboratories for research, measurement and application of light sources.

8. Lasers specifically designed for medical procedures, such as laser scar removal, laser refractive eye surgery, laser cutting, etc.

9. Laser devices specifically designed and promoted for laser performances, entertainment, advertising, etc.

II. Regulatory Laws and Regulations

1, Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C- Electronic Product Radiation Control.

2, Title 21 CFR (Subchapter J, Radiological Health) Parts 1000 through1005，part 1010, part 1040

III. Regarding Exemptions

Exemption for Class I laser products.

Exemption Requirements:

The manufacturer must test and prove that the exempted Class I laser products comply with the federal performance standards contained in 21 CFR 1040.10 and 1040.11.

The manufacturer must submit at least one product report regarding any similar or different types of laser products.