DeNovo Application has finally come to realization

In the month of September FDA approved the De Novo Application for the 2 devices Zeltiq^TM Dermal Cooling Device and Erchonia ML Scanner. And hence both the devices have been reclassified from Class III devices to Class II devices.

ZeltiqTM had requested an expansion of the indication for use for their Dermal Cooling devices. The new indication for use being requested was for “cold-assisted lipolysis”. Under the De Novo process the Zeltiq Lipolysis System is indicated to affect the appearance of flanks (love handles) in subjects having a Body Mass Index (BMI) of 30.

Erchonia ML Scanner is a low level laser system. The requested indication for use was in body contouring of the waist, hips, and thighs. Under the De Novo process Erchonia ML Scanner is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

How do you benefit from this?

Both the devices were earlier classified as Class III even though they were low or moderate risk devices because they were found not substantially equivalent (NSE) to the existing devices. But through the De Novo classification the products have been reclassified from Class III to Class II devices.

If you are a medical device manufacturer or a specification developer and have a product that is substantially equivalent to the above approved devices than you can cite the above devices as your predicate in your 510(k) application.

So if you are a manufacturer or specification developer whose device is substantially equivalent to Erchonia ML scanner or Zeltiq Dermal Cooling device and would like to know more about obtaining the clearance for your device then contact us at info@mdiconsultants.com and put “NewDev” in the subject line.

If you have want to know more about De Novo process and want to discuss if your device qualifies for it then please contact us at info@mdiconsultants.com and put “De Novo” in the subject line.