DeviceClearance

Product code LEL— Neurology

A SLEEP ASSESSMENT DEVICE

Classification name
Device, Sleep Assessment
Device class
Class 2
Regulation
21 CFR 882.5050
Advisory panel
Neurology
Total cleared
19
First cleared
Most recent

Market context for product code LEL

FDA has cleared 19 devices under product code LEL between 1979 and 2025, filed by 18 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 LEL

Recent clearances under product code LEL

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