Qlaser Handheld cold laser

Warning: The Q10 and Q1000ng products were taken off the market by the FDA and the owners of the business have been indicted by the Justice Department.

The information posted here is not an endorsement for the product but it is posted for historical reasons. We have spoken to many owner of the system that liked it but the company and the owner were using several unethical practices.

The specs were never totally clear so here is what we know:

Power Level: 328mW to 64mW

Wavelength: 470-940nm

It appears that they used a combination of LED and laser diodes.

 

Effective on October 24th 2014, The FDA placed an injunction on the company that is associated with this product. Here is some of the verbiage from the Federal Government's injunction.

1. This statutory injunction proceeding is brought under the Federal Food, Drug, and Cosmetic Act (the “FDCA”), 21 U.S.C. 3 32(a), to enjoin 2035, Inc, a corporation, and Dr. Robert L. Lytle, an individual Who also goes by the name Dr. Larry Lytle and does business as 2035 Private Membership Association (“2035 PMA”) and QLasers Private Membership Association (hereafter collectively, “Defendants”), from violating:

A. 21 U.S.CI. 331(a), by introducing or delivering for introduction into interstate commerce, and/or causing the introduction or delivery for introduction into interstate commerce of, articles of device, as de?ned by 21 U.S.C. 321(h), that are adulterated Within the meaning of 21 U.S.C. 351(f)(1)(B), in that they are class III devices pursuant to 21 U.S.C. 360c (f), and they are not the subjects of approved applications for premarket approval as required by 21‘ U.S.C. 360e(a), nor are they the subjects Of an effective investigational device exemption under 21 U.S.C. 360j(g); and;

Here is the link to the PDF for the complete injunction.

www.justice.gov/sites/default/files/opa/press-releases/attachments/2014/10/24

The president/founder of Qlaser and several others associated with the business have been indicted by a federal grand jury in Rapid City, South Dakota. Robert “Larry” Lytle, 81, and Fredretta L. Eason, 76, and Canada resident Irina Kossovskaia, 62, are charged with mail fraud, wire fraud, conspiracy, contempt, and obstruction of government proceedings. Eason is charged with criminal contempt. A fourth individual, Ronald D. Weir, 38, also of Rapid City, agreed to plead guilty on Monday to related conspiracy charges contained in a separate criminal information that was filed with the U.S. District Court for the District of South Dakota. These charges follow a separate civil enforcement action brought by the United States against Lytle and his QLaser businesses in late 2014. Below is the official document about the issue:

www.justice.gov/usao-sd/pr/three-individuals-arrested-and-charged-south-dakota-fraudulent-medical-device-scheme

What can we Learn from this?

You should expect similar legal problem for most of the systems selling on Ebay. Ebay refuses to stop selling illegal medical equipment so they should eventually be a target for the FDA and justice department. The people are committing a federal crime and will go to jail when the Justice Departments tracks them down. That is why they are mainly in China and Indonesia. So, if you are buying illegal product, don't expect them to publish the real specification, have good quality or any support on the products.

Making any claims other than those approved by the FDA can result in big problems for the company and the people that run the company.

 

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