All laser light projectors with an output of over 5mW (Class 3B and Class 4 Lasers) require a “Variance”, like a laser license.
We make this application process simple for you.
There are (2) simple forms to fill in your contact information and sign.
We email them to you and you email them back. Simple as that.
We send the documents to the FDA for processing. When the FDA receives the documents, they send you a receipt document, within that document, an “Accession Number”. This accession number will serve as your proof of application and you can use this to track your progress on www.regulations.gov
After that, the Variance will be mailed to you when your turn in line comes.
If you already have a CDRH variance, enter coupon code ### varianced #/## to receive the refund. Valid variance must be shown to Laserworld prior to shipment of the products!
Only valid for laser light systems bought through Laserworld USA