Soliton, a medical device company using a Rapid Acoustic Pulse (RAP) platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center, has filed for Special 510(k) Premarket Notification with the U.S. Food and Drug Administration (FDA) for its Generation II RAP device.
Over the past two decades, body art has become mainstream, and this trend shows no signs of slowing down. As people of all ages seek to express themselves and commemorate special people and moments in their lives through permanent tattoos, the demand for tattoo removal also rises. Traditionally, treatment options were less than optimal, requiring up to a dozen sessions with poor clearance of multi-colored tattoos.
A new study published in Lasers in Surgery and Medicine on March 25 confirmed that ink particles are ejected during laser tattoo removal treatment at speeds so high that they actually become embedded in glass slides held near the treatment site. Author Michael J. Murphy found dark material, presumably fragments of the tattoo ink, on and embedded within glass slides following Q‐switched Nd:YAG laser treatment of tattoos.
The U.S. Food and Drug Administration (FDA) has cleared the DESCRIBE PFD Patch (Merz Aesthetics), a single-use, perfluorodecalin-infused clear patch used during laser treatment of tattoos, for all commonly used wavelengths for tattoo removal. The Patch, which is placed over tattoos prior to treatment, allows practitioners to perform rapid multiple laser passes in a single treatment session. It was previously cleared in April 2015 for use with the 755nm QS Alexandrite laser, which is effective in removal of tattoos with blue or black ink.
If you want to get a sense of just how popular tattoos are in the United States, you need only look at cable television listings. To date, there are more than 20 reality shows dedicated to the art of tattooing, and multiple studies have put the number of people with tattoos at anywhere from 30% to 40% of the U.S. adult population. So how does this relate to your practice? Approximately one in five of them are thinking of having their tattoos removed.
Laser manufacturer Cynosure has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its PicoSure picosecond laser for the removal of the full spectrum of tattoo inks as well as pigmented lesions.
The device’s new 1064nm wavelength aids in removal of black and other dark tattoo inks and complements the system’s existing 532nm and 755nm wavelengths. It will be offered as an upgrade to existing PicoSure customers, and initial shipments of the new 1064nm laser delivery system are expected to begin in the second half of 2016.
Syneron-Candela recently expanded its award-winning PicoWay platform to include a novel fractionated handpiece, the PicoWay Resolve, and a new ultra-short 785nm wavelength, the first of its kind in the aesthetic market utilizing a titanium sapphire laser for removal of blue and green inks. The platform now includes both fractional and nonfractional 532nm and 1064nm picosecond wavelengths for the treatment of benign pigmented lesions and tattoos, plus the 785nm wavelength, which further reduces pulse duration to address smaller ink particles.
In a pilot study to investigate laser tattoo removal through a perfluorodecalin (PFD)-infused patch (DeScribe, ON Light Sciences), Brian S. Biesman, MD, FACS, et al, found that the patch conclusively demonstrated faster clearance than typical single-pass treatments.
In a prospective study published in Lasers in Surgery and Medicine (September 2015), researchers used a prototype, picosecond-domain, frequency-doubled Nd:YAG laser system (PicoWay, Syneron-Candela) to treat 31 tattoos in 21 subjects.
Tattoo removal has come a long way since the introduction of Q-switched lasers 25 years ago. Their nanosecond energy pulses allowed physicians to remove many inked images without the risk of scarring, and as equipment improved, systems with multiple wavelengths, adjustable fluences and variable spot sizes let skilled practitioners improve outcomes further. Still the tattoo removal process remained largely unpredictable, expensive and time-consuming.
