• Profile
Close

Alma, a Sisram Medical Company, receives notice of completion of inquiry from FDA for FemiLift Pixel CO2 System

PTI Dec 11, 2018

Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced on December 10 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.

Only Doctors with an M3 India account can read this article. Sign up for free or login with your existing account.
4 reasons why Doctors love M3 India
  • Exclusive Write-ups & Webinars by KOLs

  • Nonloggedininfinity icon
    Daily Quiz by specialty
  • Nonloggedinlock icon
    Paid Market Research Surveys
  • Case discussions, News & Journals' summaries
Sign-up / Log In
x
M3 app logo
Choose easy access to M3 India from your mobile!


M3 instruc arrow
Add M3 India to your Home screen
Tap  Chrome menu  and select "Add to Home screen" to pin the M3 India App to your Home screen
Okay