Fat Reducing Low Level Laser

What Is This Device?

Non-invasive reduction in fat layer for body contouring

How Is OLI Classified?

Fat Reducing Low Level Laser is FDA product code OLI, 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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 3 clearances under this code; the FDA took a median of 89 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2014. None was by a company in China. The root cause the FDA records most often is No Marketing Application (3).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.