CDRH Laser Classification
Our lasers come standard with CDRH classification. If your laser is custom-made, it may not include all the required safety features. It will still obtain classification (you will know in which class it belongs), but it will be considered an OEM product; not a standalone unit (a complete laser system). Your laser does not need to be a standalone with all the safety features unless you require it to be so. An OEM product should only be used as part of a system and cannot be considered a standalone unit. It is the responsibility of the system manufacturer using an OEM product to make sure that its system includes all the required safety features to comply with CDRH regulations. Please mention it at the time of order. However, end users (those planning to use the laser as is - wihout incorporating it inside a system) MUST order it with all the required safety features.
If you would like your laser to include all the safety features required by CDRH, then the following criteria must be met for each safety class.
class II & IIIa
Your laser must have...
- a laser radiation emission indicator (LED that lights up when laser lights up)
- a beam attenuator (a cap, or, for a Magnum, a shutter)
- a Warning/ID/Aperture label affixed (sticker on the laser with all the required information)
- an instruction manual
class IIIb
Your laser must have...
- all items mentioned for class II & class IIIa above
- a removable key-actuated master control preventing lasing when removed
- a remote interlock connector that prevents lasing when removed
- a laser radiation emission indicator that turns on prior to lasing (LED that lights up 5-10 seconds before the laser lights up)
- an On/Off switch (although this feature is standard on our class II & IIIa lasers)
Note that Magnum lasers come standard with all these features. For all other lasers, a special keybox must be ordered to fulfill criteria 2, 3, and 4.
class IV
Your laser must have...
- all items mentioned for class IIIb above
- a manual reset mechanism (integrated into all class IV lasers)