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Chris C.
Chris C., Nurse
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Experience:  Nurse with with 10+ yrs. in wellness care, geriatrics, hospice and acute care.
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I am wondering if I can buy an I-lipo machine for personal

Resolved Question:

I am wondering if I can buy an I-lipo machine for personal use.

http://www.ilipo.com/us/

In Utah they passed a law on July 31, 2013 that only chiropractors and MD's can oversee the use of lasers in med spas, but what about personal use?

Does anything stop me from buying a non surgical lipo laser device to use on myself?
Submitted: 1 year ago.
Category: Health
Expert:  Chris C. replied 1 year ago.

Chris C. :

Hello! I will be assisting you today.

Chris C. :

These medical laser devices are covered under FDA guidelines and cannot by purchased by an unlicensed person. These are also not to be used by law except "under the direct supervision of a medical doctor" according to the FDA. The FDA regulates all prescriptions and also all medical devices. They determine if a home consumer can use any device or if they need a prescription to purchase.

Chris C. :

All medical devices are classed as doctor only devices.

Chris C. :


"Ablative procedure" means a procedure that is expected to excise, vaporize, disintegrate, or remove living tissue, including the use of carbon dioxide lasers and erbium:YAG lasers, and excluding hair removal."


Chris C. :

Covered under Utah law as well located here:

Chris C. :

Did you see my reply?

Customer:

yes, please switch to q&a mode

Expert:  Chris C. replied 1 year ago.
I have switched to Q&A already. Exit chat and reenter.
Expert:  Chris C. replied 1 year ago.
Chris C. :

Hello! I will be assisting you today.

Chris C. :

These medical laser devices are covered under FDA guidelines and cannot by purchased by an unlicensed person. These are also not to be used by law except "under the direct supervision of a medical doctor" according to the FDA. The FDA regulates all prescriptions and also all medical devices. They determine if a home consumer can use any device or if they need a prescription to purchase.

Chris C. :

All medical devices are classed as doctor only devices.

Chris C. :

"Ablative procedure" means a procedure that is expected to excise, vaporize, disintegrate, or remove living tissue, including the use of carbon dioxide lasers and erbium:YAG lasers, and excluding hair removal."


Chris C. :

Covered under Utah law as well located here:

Chris C. :

http://www.dopl.utah.gov/laws/58-67.pdf

Chris C. :

Did you see my reply?

Customer: replied 1 year ago.

I have a Triton DTS spinal decompression table. I was able to buy it with a prescription. Durable medical equipment is allowed to be bought for home use with a prescription.


 


Are lasers never allowed for home use even with a prescription?

Expert:  Chris C. replied 1 year ago.
That is correct. Some devices like a cpap, decompression table, nebulizer, etc can be used in the home with prescription. However, medical lasers according to the FDA federal guidelines and your Utah law (and all other states that I am aware of) are never allowed even by prescription. This is due to the fact that they can only be used by or under the direct supervision of a licensed doctor. The reason this is not an allowed device is that it can do permanent damage if not used properly so a qualified person is the only one allowed to operate it according to the medical device laws.
Customer: replied 1 year ago.

in Utah a chiropractor and an MD can oversee laser use.


 


Two follow up questions:


1. Can a licensed nurse practitioner oversee the lasers like a doctor or chiro?


2. What is required for the technician who actually does the laser procedure? Does it require a licensed aesthetician or just a lay person under the supervision of a licensed professional?

Expert:  Chris C. replied 1 year ago.
In Utah: Cosmetic medical device" means tissue altering energy based devices that have the potential for altering living tissue and that are use to perform ablative or nonablative procedures, such as American National Standards Institute (ANSI) designated Class IIIb and Class IV lasers, intense pulsed light, radio frequency devices, and lipolytic devices, and excludes ANSI designated Class IIIa and lower powered devices. (b) Notwithstanding Subsection (5)(a), if an ANSI designated Class IIIa and lower powered device is being used to perform an ablative procedure, the device is included in the definition of cosmetic medical device under Subsection (5)(a).



This will explain the credentials required: http://www.lasertraining.org/Administrative/Library/LaserLicensing&Credentialing0906.pdf

Be aware that as this states:

Use of Lasers by Non-Physicians:
Here we're referring to patient treatments with lasers by non-physicians - mostly with non-ablative cosmetic laser procedures. These include primarily laser hair removal and skin rejuvenation, but can also include treatment of small blood vessels (telangiectasia, spider veins, etc) or pigmented lesions (age spots, freckles, etc). It generally DOES NOT include use of ablative skin resurfacing lasers such as CO2
or Er:Yag which are much more invasive and therefore performed directly by the physician, although fractional resurfacing is much less invasive and a case can be made for its safe performance by properly trained nurses or advanced level technicians.


It is common practice to have untrained persons using these lasers but in many settings including spas, etc but according to the licensing board in most places it is not allowed.
Chris C., Nurse
Category: Health
Satisfied Customers: 985
Experience: Nurse with with 10+ yrs. in wellness care, geriatrics, hospice and acute care.
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Chris C.
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Nurse with with 10+ yrs. in wellness care, geriatrics, hospice and acute care.