Types oflaser

Your firm may begin to produce laser light shows only after receipt of a variance approval letter from FDA indicating the conditions under which you may produce the laser light show or distribute laser light show projectors.

All applicable documents, including the CDRH Cover Sheet should be emailed to the CDRH at: RadHealthCustomerService@fda.hhs.gov.

Please note our UV Flashlights are intended for curing small resin projects (less than 2" diameter), like our Fly Fishing Resins.  Yes it can cure our liquid resins but for larger projects you will need a professional and reasonably powerful artificial UV light source such as fluorescent tanning / bronzing lamps (UV-A), mercury vapor UVlamps, or UV-A LED lights (385nm).  Full direct Sunlight is a great way to cure Solarez UV resins.

10 uses oflaser

There are several options for documents to submit.  For example, if you are purchasing a certified laser projector for which a product report has already been submitted, you need only submit the laser light show report and variance application.

You no longer need to separately send variance applications to Dockets Management Staff (formerly titled Division of Dockets Management).

Lasers and laser projection systems are used with other optical equipment, such as projection screens, mirror balls, remote projector heads, and fiber optics, to produce colorful, dramatic displays for entertainment purposes.

Properties oflaser

When used in the proper setting and handled by qualified professionals, laser light shows can provide dramatic displays and as backdrops to other entertainment and venues.

“Demonstration laser product means a laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition.”

How doesa laserwork

Laser stands for Light Amplification by the Stimulated Emission of Radiation. One basic type of laser consists of a sealed tube, containing a pair of mirrors, and a laser medium that is excited by some form of energy to produce visible light, or invisible ultraviolet or infrared radiation. Ordinary light, such as that from a light bulb, has many wavelengths and spreads in all directions. Laser light, however, has a specific wavelength. It can be focused into a tight beam and can concentrate very high-intensity light at large distances from the laser.

Manufacturers of laser products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005:

The .gov means it’s official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Laser products promoted for demonstration purposes are limited to hazard Class IIIa by FDA regulation 21 CFR 1040.11(c). This means that projectors are limited to 5 milliwatts output power in the visible wavelength range from 400 to 710 nanometers. There are also limits for any invisible wavelengths and for short pulses. Laser light show projectors therefore may not exceed the accessible emission limits of CDRH Class IIIa. Laser light show manufacturers must submit a variance request for FDA approval in order to sell and operate higher class (Class IIIb and IV) laser light show equipment.

What is a laser lightmade of

JavaScript seems to be disabled in your browser. For the best experience on our site, be sure to turn on Javascript in your browser.

These submissions must be prepared with either the fillable PDF forms available below or using the eSubmitter electronic submissions software.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

*The act of assembly of a laser light show using a previously manufactured laser or laser product results in the creation or manufacture of a “new” product.  The creation of this new product may involve the addition of such components as display screens, mirrors, smoke/fog and optics but may result from merely changing the intent and use of the original laser. Hence, the person who produces the “new” product is considered a “manufacturer” if such person is engaged in the business of manufacturing laser light shows. This policy, including additional details, can be found in Laser Notice #22, published on November 22, 1977.

LASERfull form

CDRH recommends that you fill out the new CDRH Variance Package Cover Sheet  and submit it to CDRH along with the required forms to make certain that the applicant and submitter have followed the necessary instructions and to clarify to the CDRH Document Control Center (DCC) staff what is being submitted.  See CDRH Variance Package Cover Sheet available under the ‘Submission Documents’ section below.

Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control.

Newest technology SMD ultra high output flashlight. Cures Solarez resin with the correct wavelength. Typically cures Solarez resin in 30 seconds or less. To reduce resin shrinkage and yellowing you can attenuate the light by moving the flashlight on and off the project. This flashlight takes one 3.7V 18650 battery. You can purchase our Battery Charger Kit. Which contains two 3.7 volt ROEN® rechargeable battery to power your flashlight.

In addition, laser products must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1040:

Manufacturers of laser products can request an alternate means of providing radiation safety; this is called a Variance:

What is laserin Physics

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

The old-style "bulb-like" LEDs from the 1980's or '90's are obsolete compared to today's SMD (sheet mounted diodes) style chips. They GREATLY exceed the bulb-style lights output, no matter how many of them you have i.e. you can have a bulb-style LED flashlight that has 64 bulbs and still not have nearly the intensity as a single SMD LED.

What is a laser lightused for

Prior to using Class IIIb and IV lasers for a laser light show in the United States, the following documents must be submitted to the FDA by the responsible parties:

SOLAREZ UV flashlights choose to use "Button-Top" Lithium Ion 18650 batteries because they have long-lasting power for thousands of short bursts and are rechargeable many times. There are "flat-Top" 18650 batteries designed for "vaping" machines but these are designed for high-intensity discharges for the vaping needs. Don't use these in Solarez flashlights. Also, don't use two CR-123 batteries in series. The voltage is too high.

SOLAREZ resins require 385nm to cure properly. If you use a 365nm flashlight or a 395nm or a 405nm, you may get a tacky surface cure or perhaps inadequate adhesion to the base or sometimes a liquid vacuole may appear. All aberrations associated with improper lighting

Unlike broad-spectrum fluorescent tanning lamps or mercury vapor UV lamps, UV LED flashlights are very specific. Their wavelength varies by only by ±5nm. If they are 365nm, the only put out 360nm - 370nm (NOT 385nm). If they are 395nm, they only put out 390nm - 400nm, (NOT 385nm). If they are 405nm, they only put out 400nm - 410nm (NOT 385)

There have been so many regulations and changes with respect to the AIR shipping of Lithium batteries that we have decided to sell this flashlight WITHOUT batteries. That way, this flashlight can ship ANYWHERE. We do offer a complete kit with charger and batteries but it is available only to the lower 48 United States. Sorry for any inconvenience.

While the lasers themselves can cause injuries, laser light shows that are produced in accordance with FDA regulations keep hazardous lasers away from the audience. For shows where the laser beam could fall on the crowd, the power of the laser is kept below levels know to be hazardous.