DeviceClearance

Product code PLU— Neurology

Cereve Sleep System

Classification name
Thermal System For Insomnia
Device class
Class 2
Regulation
21 CFR 882.5700
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface.”

— U.S. Food and Drug Administration, device classification record for product code PLU under 21 CFR 882.5700, via openFDA

Market context for product code PLU

FDA has cleared 1 device under product code PLU, all in 2016, filed by 1 applicant company. 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.

Top applicants under product code PLU

Recent clearances under product code PLU

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