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The ML830® is NOT a Class 4 laser.

FDA WARNING on Class 4 Lasers: "Immediate skin hazard and eye hazard from exposure to either the direct or reflected beam; may also present a fire hazard."

What is a Class 4 Laser?

FDA - Description of Class 4 Laser (Laser Product Hazard): Immediate skin hazard and eye hazard from exposure to either the direct or reflected beam; may also present a FIRE HAZARD

Wikepedia: Class 4 lasers CAN BURN SKIN, and in some cases, even scattered light can cause eye and/or skin damage.

Europe (EN & IEC): Class 4 is the highest class of laser radiation. Radiation in this class is very dangerous, and viewing of the diffuse reflection may be dangerous. Class 4 laser beams are CAPABLE OF SETTING FIRE to materials onto which they are projected.

A Class IV laser is a high output instrument, greater than 500 milliwatts, often much higher. It poses potentially serious hazards to the skin and eyes. They may, on occasion, even pose a fire hazard. A log of usage must be maintained and a laser safety officer must be assigned. Surgical lasers and some therapeutic lasers (which generate heat and can cause thermal injury) fall within this category. A class IV therapeutic laser has the disadvantage of generating heat and potentially damaging tissues.

Are they safe?

No, they are very dangerous! You should be very careful if you decide to buy one of these lasers. There is a reason the FDA has classified them, "Class 4".

Class IIIa & IIIb lasers generate no heat, and are proven (20+ years) of being VERY SAFE. They are commonily referred to as "Cold Lasers". They can be used for an unlimited amount of time, without generating heat or causing harm to your patients.

Class 4 lasers are VERY DIFFERENT. If you use one of these devices for several minutes, you could cause serious harm to your patients. Most Class 4 operating guides, warn about prolonged exposure. They consider a few minutes, prolonged exposure.

If they were "Cold Lasers", why the warning? "Cold Lasers" do not produce any heat and can be used for any duration of time.

Class III Laser Therapy vs Class 4 Laser Therapy

The international system of laser classification is concerned only with the risk for eye injury and, at higher powers, skin damage. It has nothing at all to do with suitability for laser treatment, nor does it mean a generational change nor ensure any improvement in efficacy. Many different parameters are considered in eye risk evaluation (laser wavelength, beam diameter, beam divergence, exposure time, pulsing vs continuous emission, type of pulsing and more). Actually there are Class I lasers that are higher powered than many Class IV instruments! So, there is no sense in or reason for, other than deception, the term "Class IV laser therapy". For example, some manufacturers claim that their Class IV lasers (e.g. 10-60 W, 980 nm laser) offer superb penetration through tissue (from 6-to-9 inches according to one manufacturer), and that the so-called "weak" class IIIB lasers (e.g. 500 mW, 808 nm laser) hardly penetrate the surface skin barrier at all. However, in the chosen example below, the very opposite is the truth! Due primarily to its absorption by water in the tissue, 980 nm penetrates less than 808 nm, and this is not compensated by the higher power. At around 808 nm we actually have the best penetration into tissue, and increasing power only increases the depth of penetration marginally. With the higher superficial absorbance of the 980 nm laser there will be considerable heating, and, while heat is fine for many conditions, it is not of what photomedicine is constituted. It is also interesting to note the use of the term "Class IV technology". There is no specific "technology" that enables a manufacturer to choose a laser emitter that produces more than 500 mW, thus the term "Class IV technology" is simply used to infer a differential benefit that does not exist. Apart from power, the only differences between Class IIIB and IV lasers are the potential hazards and, usually, the price.

High Power Vs. Low Power

There are two extremes on the market – those promoting very low power output and those promoting very high power output. Which is best? The answer is: none of them. There is no "one size fits all" laser. Each one has its limitation. There is an increased awareness about the necessity to deliver fairly low doses over longer time to optimize anti-inflammatory results (Castano et al 2007, as one example). This means that, at least for healing processes, low power over long time is more effective than high power over short time, even if the total energy is the same. The same goes for stimulation of cell proliferation. For temporary analgesia of painful conditions, high power over short time can give a better momentary effect, subject to certain minimum-time and maximum-power thresholds. The optimal dose windows for musculoskeletal indications, based upon the current scientific evidence, can be found at Conclusion: very high powered lasers are useful for treating large areas in short time and to obtain pain inhibition, but seemingly less effective for basic cell stimulation and are limited by a long list of contraindications. They do not penetrate much deeper due to the high output – in fact, the very act of making a high power laser 'safe' for long-duration exposures may make it less capable of penetrating as deeply as a lower-powered laser that can e.g. be applied in contact and with slight pressure to the skin. All types of medical lasers are useful within their own limitations, but the very high powered lasers are still lacking scientific documentation in spite of their increasing popularity with salesmen and their less informed customers.

Class IV Laser Biphasic Dose Biphasic Dose Response in Low Level Light Therapy: Ying-Ying Huang; Aaron C.-H. Chen; James D. Carroll; Michael R. Hamblin (4.1 Megabytes)

Read what the Experts have to say about Class 4 Lasers:

How Not to Promote Laser Therapy by Tuner, Hode, & Jenkins (527 Kb)

90 Day Cold Laser Therapy Equipment Trial