Merz North America Announces New FDA Clearance for Describe® PFD Patch. Describe®, the first and only accessory for laser-assisted tattoo removal, is cleared for use with additional lasers and wavelengths
Merz North America announced today the DESCRIBE® PFD Patch has been cleared by the Food and Drug Administration (FDA) for all commonly used lasers for tattoo removal. The Patch, which is placed over tattoos prior to removal with a laser, allows physicians to treat tattoos more efficiently by enabling rapid multiple laser passes in a single treatment session.
The Patch was previously cleared in April 2015 for use with the 755 nm QS Alexandrite laser, which is effective in removal of tattoos with blue or black ink. This clearance now includes use of the 532, 694, 755 and 1064 nm standard Q-Switched (QS) lasers and 532, 755, 785 and 1064 nm standard picosecond lasers in Fitzpatrick Skin Type I-III patients. The expanded indication allows the Patch to be used with all commonly used lasers, providing the capability to remove tattoos across a spectrum of colors. The FDA clearance also extends the shelf life of the Patch from two years to three years.
“Physicians and our patients wanted to be able to use DESCRIBE with a variety of lasers on tattoos of all colors, and a recent study shows that this is now possible,” said Jeremy A. Brauer, M.D., lead author of the study presented at the 2017 annual meeting of the American Society of Dermatologic Surgery.i “With this clearance extension we can use the Patch as an accessory with commonly used lasers and wavelengths for tattoo removal.”
The DESCRIBE® PFD Patch is a single-use, perfluorodecalin-infused gel- based skin barrier and optical clearing device accessory for use during laser treatment of tattoos. Additionally, as certain wavelengths are more effective at removing specific pigment colors, when using the correct wavelength, the Patch can be used to aid in removal of colored tattoos.
“Tattoo removal is the third fastest growing non-surgical cosmetic procedureii, but historically the treatment has taken a year or more to be completed,” said Bob Rhatigan, CEO of Merz North America. “The Patch offers physicians and their patients a faster, safer and more effective option than without the patch alone. Innovations, like DESCRIBE, exemplify our ongoing commitment to help patients live better, feel better and look better.”
For more information, visit https://www.describepatch.com/ifu/.
About DESCRIBE® PFD Patch
The DESCRIBE PFD Patch is dual-layer silicone patch infused with the optical clearing agent perfluorodecalin (PFD) that quickly resolves the laser induced whitening to allow for multiple laser passes in a single treatment session. The DESCRIBE Patch is a single-use, optical clearing device accessory for use in laser-assisted tattoo removal procedures. Side effects, including pain, erythema and edema were reported during laser tattoo removal. For full product and safety information, please visit DescribePatch.com/IFU.
12.04.2017 [ 0 KB ]