Alma, a Sisram Medical Company, Receives Notice of Completion of Inquiry from FDA for FemiLift[TM] Pixel CO2 System
CAESAREA, Israel, December 4, 2018
CAESAREA, Israel, December 4, 2018 /PRNewswire/ --
Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a notice of completion from the US Food and Drug Administration (FDA) in response to questions about marketing and promotional language concerning the Company's FemiLift Pixel CO2 system used for dermatological, surgical and gynecological health procedures.
"We take compliance with FDA regulatory requirements seriously and we took immediate action following the July notice to work with the FDA to review and resolve their questions," said Lior Dayan, CEO of Alma Lasers, Ltd. "We are pleased to have collaboratively brought this matter to a close, and we will continue to ensure that all of our products are promoted according to FDA regulations."
The FemiLift Pixel CO2 system is a high-powered, multi-application CO2 laser that delivers focused and fractional 10,600-nm laser in a precision beam in addressing dermatological, surgical and gynecological health procedures requiring ablation, vaporization, excision, incision and/or coagulation of soft tissue. FemiLift takes a pixelated approach to tissue resurfacing by targeting only a fraction of the tissue while leaving the remaining microscopically untreated tissue to aid in rapid healing.
Alma is a global innovator of Laser, Light-based, Radiofrequency, Plasma and Ultrasound solutions for the aesthetic and surgical markets. We enable practitioners to offer safe and effective procedures while allowing patients to benefit from state-of-the-art, clinically proven technologies and treatments.
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