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Laser Compliance > FAQ On Laser Products

Laser Regulations Frequently Asked Questions (FAQ)

The maze of government laser regulations can be hard to understand. Below are some of the most common questions about laser compliance that we have received. The questions and answers are divided into four major sections:

Designing your laser product for compliance

Laser regulations and definitions for U.S. compliance

Penalties for non-compliance

How Laser Compliance® helps you

Designing Your Laser Product for Compliance

Q: If we build a laser product, why do we need to do anything special?

A: In the U.S. and other countries, products containing lasers must follow specified regulations. The manufacturer and/or importer is required to certify that the laser product conforms to the regulations.

Q: Can we sell our product if it isn’t certified?

A: With a few exceptions, no. Some OEM and export products need not be certified, but they must still be properly reported. OEM products may not be sold to end users.

Q: Can a product be evaluated before it exists?

A: Yes. Many laser products and potential laser products can be carefully evaluated and classified during the planning or engineering stages if some key parameters are known.

Laser Compliance® can work with you in the design stages, to determine the laser class as designed. We can also suggest any modifications so your product achieves the most favorable regulatory status possible.

Regulations and Definitions for U.S. Compliance

Laser regulations in the U.S. are currently the most stringent in the world. This section concentrates on U.S. laws and contains some of the most common questions about laser compliance. The same general principles also apply to European/IEC certification.

Q: What laws or regulations govern laser products in the U.S.?

A: The U.S. Federal Laser Product Performance Standard (FLPPS) requires all lasers, laser systems and laser products and manufacturers to comply with specific laser regulations. These can be found in the U.S. Code of Federal Register (CFR 21 subchapter J, Part I sections 1002 – 1040.11 )

Q: Who administers Laser Regulations?

A: Laser product requirements are inspected and enforced by a division of the U.S. Food and Drug Administration (FDA) called the “Office of Compliance” of the “Center for Devices and Radiological Health” (CDRH).

Q: What is “certification”?

A: Certification is a statement which appears on each laser product indicating that the product is in compliance with the legal requirements for laser products.

Q: Who certifies our laser product?

A: You do, as the manufacturer or importer. You must certify that each product meets the requirements in a process of “self-certification”. The certification always must be based on a test of the product.

Working with Laser Compliance® makes the certification process much easier. We do most of the work for you. You merely need to review our analysis and paperwork, before signing it. We also make sure all applicable laser regulations are covered.

Q: We distribute laser products made by [or imported by] another company. Do we need to certify the product as well?

A: No. Certification is the responsibility of the manufacturer or the importer. They cannot place this burden on distributors. However, for your own protection, you should confirm that the product you distribute has been properly certified. If you have any questions, contact Laser Compliance®; we can run a quick, low-cost check for you.

Q: When do we need to certify our laser product?

A: Each laser product must be certified before it is “entered into commerce”, or offered for sale. Generally, this means that a product should be fully reported prior to introduction at a tradeshow, etc.

Q: Do all lasers in the U.S. have to be certified, or are there exceptions?

A: There are a few minor exceptions to being certified. If a laser or laser product is manufactured as an OEM component for another manufacturer of laser products, this may be delivered without being certified, due to the fact that the end product manufacturer will be certifying the end product. Products may also be manufactured for export without being certified, under specific parameters.

Import and export questions

Q: What about importing products from other countries?

A: Importing lasers and laser products into the US must meet all of the laser regulations and requirements for laser products which are manufactured in the US. In many cases, laser products which are imported into the US and are not certified, will be stopped by US Customs and impounded. Getting laser products released into the US from Customs impound is very costly and time consuming.

Q: Do I need to do anything special to export laser products from the US?

A: Yes. The export of lasers and laser products requires the product to be compliant with the requirements of the destination country. And, lasers must pass the restrictions of the Bureau of Export Administration (BXA).

Q: If I import certified laser products to the US, do I have to do anything else?

A: Yes. Even certified imported products must be registered.

Definitions: Laser Product and Laser System

Q: What is the definition of a “Laser Product”?

A: Roughly speaking, a Laser Product is any device that incorporates a laser, or is intended to incorporate a laser.

Q: What is the difference between a “Laser System” and a “Laser Product”?

A: A Laser System is the optical head and power supply used together to generate laser light. A Laser Product is a device that integrates a laser system for another purpose.

Q: Are Laser Systems and Laser Products regulated in different ways?

A: Yes, they are. We can provide details.

Q: Are all laser products handled the same way?

A: No. Some laser products have additional special requirements or must meet more laser regulations depending on their intended use. An example of this is lasers used for lightshows or information display.

Definitions: Variance and Laser Class level

Q: What is a “Variance”?

A: A “Variance” is a special permit granted by the CDRH which allows a manufacturer to deviate from specific legal requirements under some circumstances. An example of this is when laser displays wish to exceed the 5mW power limit for this type of projection. By showing other adequate alternative means of radiation protection, the government may grant a special circumstance permit to exceed this low power level.

Q: What is a laser “Class”?

A: Lasers are classified into different groups called “classes” based on the hazard they present. This in turn, based on the emitted power of the laser, the wavelength, human accessibility and other parameters. These classes are I, II IIa, IIIa, IIIb and IV for the U.S., and 1, 1M, 2,2M, 3R, 3B and 4 for Europe.

Q: Why do we care what class our laser product falls into?

A: The class of a laser product determines many parameters such as requirements for performance features, labeling, informational requirements, reporting, use, potential hazard, etc. Some types of products cannot be built and sold without special permits or other consideration.

Requirements for OEM manufacturers

Q: What does OEM mean?

A: OEM stands for “Original Equipment Manufacturer”. OEM products are usually purchased as components for larger systems. In example, a manufacturer of laser based medical instruments may build their instrument around an OEM laser purchased from a laser manufacturer.

Q: If we build an OEM product does this mean we don’t have to do anything with the CDRH?

A: No. Even OEM laser products which are built or imported must be registered with the CDRH.

Penalties for non-compliance with laser compliance

For additional details, see U.S. penalties for non-compliance

Q: What happens if I don’t certify my product prior to sale and distribution in the US?

A: If you sell or distribute non-compliant laser products in the U.S. you will be required to undertake a Corrective Action program to fix this problem. Corrective Actions usually require a recall with one or more of the following actions:

1. The manufacturer refunds the full sale price of the unit.
2. The manufacturer repairs each unit free of cost to the customer.
3. The manufacturer purchases each unit back from the customers.

It is not uncommon for manufacturers to spend several hundred thousand dollars on Corrective Action programs.

Q: What are the penalties for selling uncertified laser products?

A: Usually the CDRH starts by requiring the manufacturer to develop a Corrective Action program. Implementing the program can be costly due to the time and complexity involved. If problems persist, the FDA/CDRH can impose US$300,000 fines.

Q: Am I in trouble if I’ve been selling an uncertified laser product in the US?

A: Strictly speaking, when you become aware of the distribution of uncertified laser product, you are required to report it to the CDRH. They will then likely require you to perform a Corrective Action for those units already distributed.

Q: I just found out my product, already on the market in the U.S., is not certified. What should I do?

A: You should stop and solve the problem now. This is required by law. It also will show the CDRH that you have good intentions in fixing the situation.

Contact Laser Compliance® for immediate assistance. We'll explain your options.
     We'll also help when you contact the CDRH, so that you don't make the problem
     any worse.

How Laser Compliance helps you

Q: What services does Laser Compliance® provide?

A: We provide two main services:

1. Helping you avoid potential problems at the design and engineering stage, and
2. Helping you negotiate the many requirements of different agencies, so that your product is properly and legally certified.

Because of the complexity and specialization of these areas, we believe our services will pay for themselves many times over.

Q: Can't we just fill out the paperwork ourselves?

A: It is possible, in the same way that you could do your company's taxes and accounting yourself, or that you could represent yourself in court. But these areas can be difficult to understand -- and mistakes can have significant consequences. It is the same with laser product safety regulations. You probably don't deal with certification and compliance often enough to feel comfortable that the process has been done correctly. At Laser Compliance®, we make it easy for you.

Q: When should we talk to Laser Compliance® about making our product legal?

A: Our advice is to discuss your laser product compliance immediately. Talk to a Laser Compliance® professional during your planning stage, even before engineering begins, or as soon as possible thereafter.

Q: Why should we talk to you BEFORE we start designing our product?

A: In many cases, the commercial feasibility of a laser product depends on the legal laser regulations & requirements placed on it by its function and its class. Additionally, you need to know what engineering requirements are going to be required. You don’t want to finish the design and then find out that the product needs additional features and controls to be legal.

Q: We already have a product designed and manufactured. Will this be a problem in getting compliance?

A: There will be a problem if additional required controls are needed, such as emission indicator lights. Each product will need individual review to determine if this is the case.

Q: Will Laser Compliance® report our company to the government if it discovers we are not currently following the laser regulations and requirements?

A: No. We do not police compliance. Our mission is to help you achieve compliance and to help you abide by all requirements and regulations. All interactions are completely confidential.

Q: We are manufacturing in [country A] and importing into [country B]. Can you help us?

A: Yes, we are worldwide experts. Because laser regulations in the U.S. are currently the most stringent, most of our customers request assistance in this area. Whether it is internal regulations, or import/export restrictions, we can help.

Q: We plan to sell our product in both the U.S. and Europe. What should we watch out for?

A: Some companies have put U.S. labels on IEC (European) certified products -- but this does not meet U.S. requirements. The product likely will be banned until U.S. certification takes place. Fortunately, it is possible to design and certify a product to meet both regions' regulations.

Laser Compliance® can provide valuable insight in this area. Your product can be designed and certified to a common standard, meeting both U.S. and IEC requirements Depending on the product and quantities, this commonality can save literally millions of dollars.

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