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Regulatory Status of YOLO MEDICAL Inc. Lapex BCS, Lucia & YOLO Curve:
The Lapex 2000 510(k) (k034009), Lapex BCS 510(k)(k081962), Lucia 510(k)(k102375) and YOLO Curve 510(k)(k110324) are cleared by USFDA with indication intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

According to FDA guidelines, devices can only be promoted, advertised and marketed for the indication that they are approved for.

For additional information, contact the FDA directly at: 1.888.463.6332 or visit them online at www.fda.gov.

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WHAT IS A LASER?


Laser is an acronym for Light Amplification by the Stimulated Emission of Radiation. Laser devices create a uniform and coherent light that is very different from an ordinary light bulb. Many lasers deliver light in an almost perfectly parallel beam (collimated) that is very close to a single wavelength which allows the Laser's light to be focused down to a tiny spot.


LASER HISTORY

  • In 1917, Albert Einstein established the theoretic foundations for the LASER and the MASER in the paper Zur Quantentheorie der Strahlung (On the Quantum Theory of Radiation).
  • In 1957, Gordon Gould published the term LASER in the paper The LASER, Light Amplification by Stimulated Emission of Radiation.
  • In 1960, Theodore H. Maiman constructed the first functioning LASER at Hughes Research Laboratories, Malibu, California using a solid-state flash lamp-pumped synthetic ruby crystal to produce red laser light.


References:
Gould, R. Gordon. "The LASER, Light Amplification by Stimulated Emission of Radiation". in Franken, P.A. and Sands, R.H. (Eds.). The Ann Arbor Conference on Optical Pumping, the University of Michigan, 15 June through 18 June 1959. pp. 128. Maiman, T.H. (1960). "Stimulated optical radiation in ruby". Nature 187 (4736): 493–494




HOW ARE LASERS CLASSIFIED


The YOLO Curve is classifieds as a Class II medical laser and Class IIIb laser. Medical Lasers used by practitioners typically have low outputs of energy and power, and are thus placed in ANSI (American National Standards Institute) Class II category. The majority of medical lasers fall into the ANSI Class III or IV categories with most surgical lasers being in ANSI Class IV. Most medical and/or surgical lasers are classified by the FDA (Food and Drug administration) as Class II or Class III medical devices.



Class I:   These types of low power lasers are not considered to pose any hazards when operated according to normal conditions and includes lasers which are completely enclosed such as fiber-optics devices, CD players and printers. These devices cannot have emissions exceeding the Maximum Permitted Exposure (MPE) under any conditions are considered to be Class I systems. Potential dangers can occur during the repair of such devices since the laser is outside of the enclosure. Warning labels are required for this class inside the unit or underneath the cover.

Class IIa Lasers:   Few lasers qualify for this class of low-power, visible light lasers. Lasers in this class do not pose a threat if the beam of light is directly viewed for periods of time less than 16 minutes or so. Visible light lasers with a total output power less than 1 milliwatt, but greater than a few microwatts.

Class II:   This class of lasers includes visible light lasers that are intense enough that viewing the beam into a human eye can cause the normal “aversion response”. An aversion response is when the eyelids close, or the head moves in order to avoid the light. It can occur within 0.25 seconds and includes the blink reflex time.


Class IIIa:   This includes those lasers emitting ultraviolet or infrared light as well as visible light. All devices within the Class I AEL (Allowed Exposure Level) with laser output between .18μm and 1mm fall in this class. (Common Laser pointers are Class IIIa laser devices.)


Class IIIb:   These include the same spectrum as Class IIIa, but increase the output levels to that of Class II AEL.


Class IV Lasers:   This class of lasers includes any that exceeds the Class II AEL. Almost every laser that produces an excess of 0.5 watts is in this class. Laser hair removal, photofacials, laser resurfacing are all Class IV lasers and are classified as medical devices that must be used or overseen by a physician.




HOW DOES LASER LIGHT DIFFER FROM OTHER LIGHT


Light is really an electromagnetic wave. Each wave has brightness and color and vibrates at a certain angle which is called polarization. This is also true for laser light but it is more parallel than any other light source. Every part of the beam travels the exact (almost) same direction causing the beam to diverge very little. With a good laser, an object at a distance of 1 km (0.6 mile) can be illuminated with a dot that is about 60 mm (2.3 inches) in radius.


Because it is so parallel, the laser can also be focused on very small diameters where the concentration of light energy becomes so great that it can be maneuvered and used it to cut or drill. It also makes it possible to illuminate and examine very tiny details. This property is used in surgical appliances and CD players.


It can also be made very monochromic, so that just one light wavelength is present. This is not the case with ordinary light sources. White light contains all the colors in the spectrum, but even a colored light, such as a red LED (Light Emitting Diode) contains continuous intervals of red wavelengths.


On the other hand, laser emissions are not usually very strong when it comes to energy content. A very powerful laser of that kind is used in laser shows and doesn't give off anymore light than an ordinary streetlight; the difference is how parallel it is.




DEFINITION OF LOW LEVEL LASER THERAPY


Low level laser therapy (LLLT) is a light source treatment that generates light of a single wavelength. LLLT emits no heat, sound, or vibration. Instead of producing a thermal effect, LLLT may act via nonthermal or photochemical reactions in the cells, also referred to as photobiology or biostimulation.