DeviceClearance

Product code PKT— General, Plastic Surgery

SculpSure

Classification name
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Device class
Class 2
Regulation
21 CFR 878.5400
Advisory panel
General, Plastic Surgery
Total cleared
19
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PKT under 21 CFR 878.5400, via openFDA

Market context for product code PKT

FDA has cleared 19 devices under product code PKT between 2015 and 2024, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PKT

Recent clearances under product code PKT

Data sourced from openFDA. This site is unofficial and independent of the FDA.