LASER GUARDIAN, LLC
SUNRISE, FLORIDA

Laser Guardian was formed in 2008 as a consulting firm to support organizations with compliance to Florida administrative code 64E-4. This code requires all commercial and public entities using hazard class 3B and 4 lasers to establish and maintain a strict laser safety program. This code is based on the ANSI Z136.1 standard for the safe use of lasers which is voluntary. However, Florida code 64E-4 is mandatory with stricter requirements than Z136.1 and non-compliance is illegal. Consulting services include FDA compliant laser process validation for medical device and pharmaceutical manufacturers. We provide laser safety program development and supporting audits as required by 64E-4 and Z136.1. Compliance to FDA 21CFR1040 is mandatory for most lasers and laser containing systems whether imported or manufactured in the United States. This regulation requires the submittal of documents that support the safety aspects of the laser or laser system. This documentation is “…based on a testing program in accordance with good manufacturing practices”. The previous quote is from FDA form 3632 which is used for laser accession number submittals. Laser Guardian will develop submittal documentation based on years of experience working with the FDA. Laser Guardian provides expert support for entities throughout the United States and Central America with Z136.1 compliance. The founder of the firm is on the ANSI Z136.1 and ANSI Z136.9 subcommittees and is a Board of Laser Safety, Certified Laser Safety Officer. He is also on the United States IEC TC 76 committee for photonic safety standards. Laser safety consulting services are covered by an Errors and Omissions liability policy. Laser Guardian has developed support capability for the law enforcement community. The common understanding was that lasers, used for illegal illumination, were primarily a nuisance. They could be mistaken for a targeting laser or create glare on an aircraft window. Most law enforcement officers may not be aware that laser hazards extend far beyond just a nuisance. High powered hand held lasers (1 watt or greater), which resemble small LED flashlights, have a 50% chance of causing detectable eye damage at 200 feet. We provide laser hazard awareness training specifically for law enforcement as well as laser eyewear for tactical, K-9 units and pilots. The goal of Laser Guardian is to provide capable broad spectrum laser support with the full confidence of our clients. WELCOME TO LASER GUARDIAN, LLC Although the benefits of lasers are almost innumerable, their use, without the proper safety controls, has caused permanent injuries and death. Laser Guardian has the experience and training to test laser systems for emissions above safe limits as defined by the FDA under regulation 21CFR1040. We also assist in developing laser safety programs compliant to state and federal regulations through implementation of the ANSI Z136.1 standard for the safe use of lasers.