Cleared Traditional

BTL-99-OC

K230657 · BTL Industries, Inc. · Neurology

Feb 2024

Decision

329d

Days

Class 2

Risk

About This 510(k) Submission

K230657 is an FDA 510(k) clearance for the BTL-99-OC, a Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (Class II — Special Controls, product code QCI), submitted by BTL Industries, Inc. (Malborough, US). The FDA issued a Cleared decision on February 1, 2024, 329 days after receiving the submission on March 9, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5802.

Submission Details

510(k) Number	K230657 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 2023
Decision Date	February 01, 2024
Days to Decision	329 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QCI — Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5802
Definition	External Device That Uses Magnetic Fields To Induce Neural Activity In The Cerebral Cortex To Treat Neurological And Psychiatric Disorders And Conditions. It Is Not Intended For Applying Or Focusing Magnetic Fields Towards Brain Areas Outside Cerebral Cortex (e.g., Cerebellum).