Our Background

WHO WE ARE: Laser Safety Associates provides laser safety consulting, Class 1 laser product and enclosure certifications, CDRH laser product reports, and laser safety training for high powered industrial laser products. Our primary customers are laser equipment suppliers, laser integrators, and laser product end-users. Our extensive background (over 75 years) as manufacturing and safety engineers, while leading General Motor's Global Laser Safety Program as Corp. Laser Safety Officers (LSOs), makes us uniquely qualified to assess and propose safety solutions for industrial laser products and associated equipment.

OUR EXPERIENCE: As a leader in the industrial laser safety, we have been providing our safety services to industry for the past 14 years. We have safety-certified over 500 laser products ranging from shoe-box sized manual marking systems, to 2-story automated laser booths with multiple robot mounted laser heads and complex load/unload automation. LSA has expertise with Trumpf, IPG, nLight, Keyence, Telesis, and many other laser systems ranging in power from 3 to 10,000 Watts. We also have practical safety experience in welding, brazing, cutting, marking, cleaning, and annealing laser processes. Most recently much of our work has been with battery laser welding systems.

OUR CUSTOMERS: LSA provides our services throughout North America. We also work with over-seas companies who are integrating laser products for the NA market. Our integrator and end-user customers include:

Class 1 Laser with embedded Class 4 Laser

Our Services

Consulting / Safety Reviews

LSA can review or consult on your laser project before the start of equipment build and/or after installation. We will evaluate enclosure designs, safety circuit designs, and safety device selection to ensure your equipment is designed to meet all ANSI and U.S. FDA/CDRH laser safety requirements. Our experience also allows us to perform detailed safety risk assessments and recommend additional best practices which will enhance the safety of your system throughout the equipment life-cycle. We also provide site safety audits and certifications of existing installed laser systems.

Laser Enclosure Safety Validation

LSA specializes in complete safety validations and certifications of laser enclosures, laser cabins and laser booths. We will evaluate the laser product as an integrated system, assist in addressing any issues, and provide a detailed report that the installed laser product complies with ANSI/IEC Class 1 laser safety requirements, and protects personnel from all foreseeable laser radiation hazards. LSA has evaluated and certified hundreds of laser enclosures for a wide range of laser processes.

More Info

FDA / CRDH Laser Product Reports

The supplier / integrator of the final laser product (e.g. the Class 1 laser product with an embedded Class 4 laser) is responsible by U.S law to submit a technical product report to the U.S Food and Drug Administration (FDA), Center for Radiological Health (CDRH). This report consists of the technical specifications of the laser system, laser product, laser process, and the safety measures provided. Laser Safety Associates can consult, assist, or prepare the FDA/CDRH Laser Product Report for the integrated laser system, and assist in obtaining the required Federal Accession Number.

Engineering / Circuit Design

LSA consists of electrical and professional engineers who can design and/or approve the safety interface from the laser system to the machine control system. Based on a safety risk assessment and the laser application, safety circuits will be designed and/or approved to meet the safety architecture and performance level required. Current industry and government standards require that the safety circuits and components (e.g., safety interlocks) be rated SIL2 or safety category 3 or 4 on systems with high hazards LSA can also provide design and/or fabrication of laser safety interface panels for your laser process.

Laser Safety Training

LSA can provide customized laser safety instruction for personnel which meet all laser safety requirements of ANSI Z136.1 and/or IEC 60825-1 industry laser safety standards. Laser Safety Awareness training (~1 hour) is typically required for most site personnel routinely working on or near lasers. Laser Safety training (~4 hours) is typically required for site Laser Safety Officers or site safety personnel. LSA can customize this training specifically for your installed laser equipment, and will provide instruction at your company location to minimize costs and make it easy for your employees to attend.

Laser Enclosure Design/Fabrication

LSA has many years experience in specifying and evaluating enclosure designs to meet the highest standards possible for laser enclosures. We can design, construct provide and/or integrate Class 1 enclosures for your laser process or coordinate with enclosure suppliers to ensure that all the best design and construction practices are comprehended to fabricate a safe and robust laser enclosure.

Overview of U.S. Regulations for Laser Product Manufacturers

Laser Product Manufacturers

Laser product manufacturers are the equipment suppliers (e.g. machine integrators) who construct a machine or enclosure which contains a high-power laser (i.e. Class 3B or Class 4) and their product is sold in commerce. Laser product manufacturers must comply with all U.S. legal regulations for lasers and laser safety.

U.S. Legal Regulations

The U.S. Federal Laser Product Performance Standard (FLPPS) requires all laser systems, laser products, and laser manufacturers to comply with specific laser safety regulations. The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is responsible for regulating radiation-emitting electronic products. These regulations can be found in the U.S. Code of Federal Register (CFR 21 subchapter J, Parts 1002 – 1040.11).

FLPPS Requirements

An FDA Laser Product Report (Form FDA 3632) must be submitted by the laser product manufacturer (i.e. machine integrator) to the U.S. FDA Center for Devices and Radiological Health (i.e. CDRH) for each model/model family of the laser product.
The completed laser product must be certified that it meets all FDA CDRH requirements.

FDA Laser Product Report Requirements

Form FDA 3632 - Guide for Preparing Product Reports for Lasers and Products Containing Lasers must be completed and submitted. The following is a summary of the types of information and attachments that are required to be included to complete the document:

Manufacturer Information
Product Identification & Details
Product Classification & Compliance with the FLPPS
Laser Technical Specifications
Levels of Accessible Radiation
Laser Radiation Path Diagram
Laser Hazard Analysis
Safety Features & Engineering Controls
Safety Interlock Switch Layout and Specifications
Safety Circuit Connections - Block diagram and electrical drawings must meet performance standards (e.g. ISO 13489-1, IEC 61508-1)
Class 1 Protective Housing Design Details
Safety labeling compliance with ANSI/IEC standards
User / Operation Manual
Quality Control Procedures and Checklists

2. Laser Product must be certified/tested that it meets requirements

a. The laser product may be self-certified by the laser product manufacturer (i.e. machine integrator).

b. The laser product may be certified by an independent (3rd party) laser safety company.

3. Laser Product Annual Reports must be submitted

Form FDA 3636 - Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products must be completed and submitted yearly to the FDA by the machine integrator. It must list by FDA accession number, the status of all laser products that have been manufactured in the prior year.

Import Requirements for lasers / laser products imported to the U.S.

The laser product must be certified before shipment to the U.S. (i.e. the Laser Product Report must have been submitted to the FDA and an accession number must have been assigned for the laser product).
Form FDA 2877 - Declaration of Electronic Products Subject to Radiation Control Standards (along with all other import documentation) must be submitted through the U.S. Customs & Border Protection to the appropriate FDA import office.
A U.S. agent or representative must be designated and assigned for the laser product.

U.S. Regulations and Industry Standards

21CFR Sub J Part 1002 Records and Reports

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-J/part-1002/subpart-B?toc=121CFR

---- FORM FDA 3632 (4/23) Guide for Preparing Product Reports on Lasers and Products Containing Lasers: https://www.fda.gov/media/72593/download

---- FORM FDA 3636 (04/23) Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products: https://www.fda.gov/media/72606/download

---- FORM FDA 2877 Declaration for Imported Electronic Products Subject to Radiation Control Standards: https://www.fda.gov/media/72236/download

21CFR Sub J Part 1010 – Performance Standards for Electronic Products: General

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-J/part-1010

-- 1010.2 Certification

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-J/part-1010/subpart-A/section-1010.2

-- 1010.3 Identification.

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-J/part-1010/subpart-A/section-1010.3

21CFR Sub J 1040 – Performance Standards for Light-Emitting Products

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-J/part-1040

ANSI Z136.1-2022 – American National Standard for Safe Use of Lasers

The industry standard for laser safety in the U.S. It can be purchased at:

https://webstore.ansi.org/standards/lia/ansiz1362022