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Alma, a Sisram Medical Company, Receives Notice of Completion of Inquiry from FDA for FemiLift Pixel CO2 System

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Press Trust of India CAESAREA
Last Updated : Dec 10 2018 | 10:20 AM IST

/ -- 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."
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First Published: Dec 10 2018 | 10:20 AM IST

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