DeviceClearance

Product code OLI— General, Plastic Surgery

BTL-9000; BTL-9000 RADIOFREQUENCY MODULE

Classification name
Fat Reducing Low Level Laser
Device class
Class 2
Regulation
21 CFR 878.5400
Advisory panel
General, Plastic Surgery
Total cleared
33
First cleared
Most recent

FDA classification definition

“Non-invasive reduction in fat layer for body contouring”

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

Market context for product code OLI

FDA has cleared 33 devices under product code OLI between 2010 and 2026, filed by 15 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 OLI

Recent clearances under product code OLI

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