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Frequently Asked Questions: Physician FAQs

ZERONA - in the Media

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To answer some of the most commonly asked questions about ZERONA, please review the topics below.

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What is ZERONA?

What is the action mechanism behind ZERONA?

What results can I expect?

Can all patients benefit?

What areas of the body can I treat?

What happens to cholesterol and triglyceride levels post ZERONA?

Do you treat obese patients (BMI>30) differently than other patients?

Is ZERONA safe?

How deep does ZERONA affect fat cells?

Why is there only a 2-week follow-up in the study?

Why should diodes be parallel?

Where are measurements taken?

When are measurements taken?

When can patients start noticing results?

How long will results last?

Is the fat simply redistributed?

Would longer treatments be more beneficial?

Why does it not work as well on patients with previous liposuction?

Why do you need to treat every 2 days?

Why 6 treatments?

Would more treatments lead to better results?

Why don’t patients lose weight?

What is Curva and why should it be used with ZERONA?

What are the side effects of Curva?

What can I do to optimize my ZERONA results?

Why should patients avoid alcohol during the ZERONA process?

Is ZERONA effective in treating obese patients?

How does ZERONA compare with other body contouring technologies?

How long has ZERONA been in use?

Is there a risk of fat embolism?

Should we begin a treatment on a patient who is currently menstruating?

What is the FDA status of ZERONA?

Is ZERONA a class II or class IIIb laser?

The answer is both. The FDA and ANSI both have their own classification system which may lead to confusion. Below is an explanation of the difference between the two classifications that regulate lasers:

ANSI (American National Standards Institute) regulates laser safety and classifies lasers from I to IV, based on how much damage to tissue (specifically eye and skin) specific wavelengths, power levels and exposure times can cause. The ZERONA device is a class IIIb device. See below for a complete description.

"Lasers and laser systems are assigned one of four broad Classes (I to IV) depending on the potential for causing biological damage. The biological basis of the hazard classes are summarized below.

• Class I : cannot emit laser radiation at known hazard levels (typically continuous wave: cw 0.4 µW at visible wavelengths). Users of Class I laser products are generally exempt from radiation hazard controls during operation and maintenance (but not necessarily during service).

Since lasers are not classified on beam access during service, most Class I industrial lasers will consist of a higher class (high power) laser enclosed in a properly interlocked and labeled protective enclosure. In some cases, the enclosure may be a room (walk-in protective housing) which requires a means to prevent operation when operators are inside the room.

Class I.A. : a special designation that is based upon a 1000-second exposure and applies only to lasers that are "not intended for viewing" such as a supermarket laser scanner. The upper power limit of Class I.A. is 4.0 mW. The emission from a Class I.A. laser is defined such that the emission does not exceed the Class I limit for an emission duration of 1000 seconds.

• Class II : low-power visible lasers that emit above Class I levels but at a radiant power not above 1 mW. The concept is that the human aversion reaction to bright light will protect a person. Only limited controls are specified.

• Class IIIA : intermediate power lasers (cw: 1-5 mW). Only hazardous for intrabeam viewing. Some limited controls are usually recommended.

NOTE: There are different logotype labeling requirements for Class IIIA lasers with a beam irradiance that does not exceed 2.5 mW/cm2 (Caution logotype) and those where the beam irradiance does exceed 2.5 mW/cm2 (Danger logotype).

• Class IIIB : moderate power lasers (cw: 5-500 mW, pulsed: 10 J/cm2 or the diffuse reflection limit, whichever is lower). In general Class IIIB lasers will not be a fire hazard, nor are they generally capable of producing a hazardous diffuse reflection. Specific controls are recommended.

• Class IV : High power lasers (cw: 500 mW, pulsed: 10 J/cm2 or the diffuse reflection limit) are hazardous to view under any condition (directly or diffusely scattered) and are a potential fire hazard and a skin hazard. Significant controls are required of Class IV laser facilities."

This classification affects who is allowed to operate a laser system and changes from state to state.

The FDA has a different classification system which regulates products in 3 classes:
• Class 1 regulates products that do not pose any health risks. Products falling under this category typically are non-therapeutic devices (diagnostic equipment, medical furniture, etc.). These products do not need to seek an approval, but simply need to file for registration with the FDA.
• Class 2 regulates products that have a therapeutic purpose and are non life-threatening - which must be backed by a predicate device. A predicate device is a device already approved which has similar specifications and indications for use to the device for which approval is being sought. Class 2 devices benefit from an expedited process known as 5-10K, which requires minimal (if any) clinical data and is typically processed within 90 days from filing. All thermal laser devices are considered class 2 based on a previously approved predicate (or a predicate of a predicate). The predicates can all be traced back (either directly or indirectly) to a CO2 laser device from Coherent Medical (now defunct) initially approved in 1969!
• Class 3 devices are considered potentially life threatening and are subject to intense scrutiny from the FDA. Devices falling under this category typically include pacemakers, drugs, etc., but also any devices for which a predicate cannot be found, i.e. ZERONA. However, upon reviewing the information submitted by Erchonia as part of its FDA submission, FDA reclassified ZERONA as a class 2 device

Who can operate the device?

How is it different from liposuction?

Does ZERONA help with skin tightening?

Does ZERONA improve the appearance of cellulite?

Can ZERONA cause cancer?

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