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Q: Can I use the PaloVia® laser on other parts of my face/body?
A: The PaloVia laser has only been clinically tested and FDA-cleared to treat the fine lines and wrinkles around and under the eye area. It has not been cleared for use on any other area or for any other skin condition.
Q: Can I substitute another gel or lotion?
A: No, you must use PaloVia Pre-Treatment Gel, which has been specially formulated and tested to work with the PaloVia laser. The PaloVia handpiece may not operate properly if used without the PaloVia Gel, if used with another lotion or gel, or if the skin is not completely dry before applying the PaloVia Gel. Such failure to operate properly can cause serious and permanent eye damage, discomfort, or skin irritation and may damage the handpiece or prevent it from treating your wrinkles.
Q: How long will the PaloVia Gel last?
A: Each 1-oz bottle of PaloVia Gel will last for approximately 60 treatment sessions. When used as directed, the single bottle provided with your laser should last for the initial four months of use. Once you begin the twice-weekly maintenance phase, each bottle of PaloVia Gel will last about seven months.
Q: When will I start to see results?
A: Although individual results vary, most people see a visible improvement in wrinkles around their eyes after one month of daily use.
Q: How is the PaloVia laser powered?
A: The PaloVia laser is powered by a lithium-ion battery. Each PaloVia Skin Renewing Laser® comes with its own charger, which plugs into a standard 110V AC electrical outlet. It takes approximately two hours to fully charge the handpiece.
Q: How long does a full battery charge last?
A: A full battery charge lasts for 3-4 sessions of treating the wrinkles around both eyes.
Q: Can I take the PaloVia laser with me on an airplane?
A: As of March 2011, the Transportation Security Administration does not include handheld lasers on its list of Prohibited Items for Travelers. If you plan to travel outside the United States, check the airline�s baggage restrictions before you pack. In addition, check the country�s voltage requirements to ensure compatibility; you may need a plug adaptor and/or a voltage converter to charge the handpiece in foreign countries. The laser will function normally with a converter/adapter.
Q: What does "FDA-cleared" mean? How does it differ from "FDA-approved?"
A: FDA-cleared medical devices are ones that the FDA has determined to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to the FDA for clearance. FDA-approved medical devices are those devices for which the FDA has approved a premarket approval (PMA) application prior to marketing. This approval process is generally reserved for high-risk medical devices and involves a more rigorous premarket review than the 510(k) pathway. The PaloVia laser is FDA-cleared through the 510(k) review process for the treatment of fine lines and wrinkles around the eye (periorbital wrinkles).
Q: Does the PaloVia laser come with a warranty?
A: Yes. Palomar tests each PaloVia laser for quality and provides a 1-year Limited Manufacturer's Warranty against defects in manufacture, materials, or workmanship under normal use conditions. For more details on the warranty, please see the PaloVia Instructions for Use booklet or visit http://www.palovia.com/customer-care/warranty-returns.
The PaloVia Skin Renewing Laser was developed by Palomar Medical Technologies, Inc., a leading manufacturer of cosmetic lasers for dermatologists and plastic surgeons.
Over the past two decades, Palomar has revolutionized laser skin treatment. In the 1990s, a global team of Palomar laser physicists and esteemed dermatologists began experimenting with non-ablative fractional laser treatments — a new technique that kept the outer layer of skin intact (�non-ablative�) and treated only a small portion ("fraction") of the skin with each application of light. In 2000, Palomar filed a patent application on its fractional laser technology and then began selling professional systems to doctors and medi-spas soon after.
Driven to make laser skin treatment more accessible and affordable, Palomar scientists began adapting the technology for use at home. The challenges were many — miniaturizing the technology, adding user-friendly features, testing to make sure it was appropriate for home use — but they succeeded. After years of clinical studies, Palomar received FDA clearance for the first at-home fractional laser clinically proven to reduce the look of fine lines and wrinkles around the eyes.
In the past, laser skin rejuvenation treatments were only available in a doctor's office. Now, with the PaloVia Skin Renewing Laser, you can treat yourself in the privacy and comfort of your own home.
Information provided by PaloVia.