What are the classification of lasers?
For visible-beam consumer lasers, there are four main classes. Each is described in more detail here: Class 2, Class 3R, Class 3B and Class 4. The first two Classes are relatively safe for eye exposure; the last two are hazardous. The chart below shows how the eye injury hazard increases as the laser’s power increases.
What is CDRH laser?
We offer CDRH Compliance services for customers who seek guidance in the certification of their new laser or laser system with the Center for Devices and Radiological Health (CDRH). The purpose of this self-certification is to assure that a laser product is compliant with CDRH’s laser safety requirements.
What are Class 3B or 4 lasers?
Class 3B lasers are normally hazardous under direct beam viewing conditions, but are normally safe when viewing diffuse reflections. Class 4 lasers are hazardous under both intrabeam and diffuse reflection viewing conditions. They may cause also skin injuries and are potential fire hazards.
What is CDRH certification?
The Center for Devices and Radiological Health (CDRH) is a division of the Food and Drug Administration (FDA) and requires that all products containing lasers that are imported or sold in the United States must be certified. U.S. laser manufacturers must report their products to the CDRH for a type of prior approval.
What is laser Class 3B?
WHAT IS A CLASS 3B LASER? Class 3B lasers are hazardous for eye exposure. They can heat skin and materials but are not considered a burn hazard. For visible-light lasers, Class 3B lasers’ output power is between 5 and 499 milliwatts.
What are Class 3B and 4 lasers used for?
as mentioned, Class 3B lasers deliver up to 500 mW per cm2, while everything above 500 mW is considered Class 4. Lasers in Class 4 are meant for burning, cutting, or evaporative purposes – in the medical field, this usually means surgery, removal of tissue, eye corrections etc.
How are lasers classified by the FDA/CDRH?
Lasers and laser systems are classified by the FDA/CDRH based on their potential to cause injury. The most relevant parameters used to classify a laser are the laser output energy , or power and wavelengths.
How do I get a CDRH approval for my laser product?
This is done by submitting a Laser Product Report. CDRH will review the report and will issue an “Accession Number” which is like a file or reference number for that product. Note that CDRH does NOT certify or approve laser products. They only review manufacturers’ self-certified reports.
What is the laser hazard classification system?
Two bodies are involved in laser hazard classification. The Center for Devices and Radiological Health (CDRH) a part of the Food & Drug Administration and The American National Standards Institute Z136.1 Safe Use of Laser Standard. Of these two it is the CDRH that laser manufacturers need to satisfy for there are minor differences between the two.
What is a Class 3R laser?
Class 3R (replacement for Class 3A) A Class 3R laser is a continuous wave laser, which may produce up to five times the emission limit for Class 1, or Class 2 lasers. Although the MPE can be exceeded, the risk of injury is low. The laser can produce no more than 5 mW in the visible region.