510(k) K212289
K212289 is an FDA 510(k) premarket notification submitted by Neuronetics, Inc. for the device "NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar". The FDA issued a decision of Substantially Equivalent on May 6, 2022. The device falls under product code QCI (Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder), a Class II device regulated under 21 CFR 882.5802. Neuronetics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2022
- Date Received
- July 21, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- Device Class
- Class II
- Regulation Number
- 882.5802
- Review Panel
- NE
- Submission Type
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).