FDA registration information and process of Laser marking machine

At present, there are many manufacturers and traders of laser products. Recently, many customers have asked about FDA registration. Products include Laser marking machine, optical fiber Laser marking machine, cutting machine, engraving machine, etc. Here is a brief introduction to the information and application process required for FDA registration of this kind of laser equipment.

 

(a) Product Name: provide the full name of the product;

(b) Product model: list in detail all the product models, varieties or classification numbers that need to be tested;

(c) Intended use of products: for example: home, office, factory, coal mine, ship, etc;

(d) Parts list: list the parts, model (classification number), rating and manufacturer of the products in detail. For insulating materials, please provide the name of raw materials.

(e) Electrical performance: for electronic and electrical products, provide electrical schematic diagram (circuit diagram), electrical performance table;

(f) Structure diagram: for most products, the structure diagram or explosion diagram, ingredient list, etc. of the products shall be provided;

(g) Photos, instructions, safety or installation instructions of the product. If the sample is not allowed to be disassembled, the laser head picture shall be provided.

FDA certification process

 

  1. Submit application form, sample and relevant information;
  1. Test and issue report;
  1. Submit to FDA for review;
  1. Pass the examination, issue the number and issue the certificate.

Laser safety level classification: generally divided into four levels.

Class I: low output laser (power less than 0.4mw). It can ensure the safety of the design without special management.

Class II: low output visible laser (power 0.4mw-1mw), usually less than 1MW, will cause dizziness, unable to think, with closed eyes to protect, generally can eliminate symptoms. Do not observe directly in the beam, and do not directly irradiate other people's eyes with a laser of less than 1MW. Avoid observing class II laser with a telephoto device.

Class III has class Ⅲ A and Ⅲ B: class Ⅲ A is a continuous laser with visible light and output 1-5MW laser beam. It is not allowed to observe I laser with distant viewing equipment, which may increase the risk. Like class II, do not observe directly in the beam or directly shoot other people's eyes with class Ⅲ a laser.

It is dangerous to observe directly in the beam with class Ⅲ B CW laser of 5-500mw. Do not use class Ⅲ B laser to directly irradiate other people's eyes, so the risk will be greater. Class IV is a high output continuous laser (more than 500MW), higher than the third level, which is dangerous for fire and diffusion reflection, especially it is worth noting. Children should avoid direct viewing of such lasers.

Conclusion: class Ⅱ, class Ⅲ a, class Ⅲ B and class Ⅳ products are harmful. Please use them under guidance and supervision. Children should pay more attention to them. Please use them under the supervision of parents or other competent guardians.