Laser for Disruption of Adipocyte Cells for Aesthetic Use

What Is It?

Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.

How Is PKT Classified?

Laser For Disruption Of Adipocyte Cells For Aesthetic Use is FDA product code PKT, Class 2, 21 CFR 878.5400.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. It is exempt from most of the quality system regulation. Chinese applicants hold 6 clearances under this code; the FDA took a median of 72 days from receipt to decision on them.