Chrysalis Intelligence · Sponsors · Neuronetics, Inc.

Neuronetics, Inc.

Malvern, PA, US · 9 510(k) clearances

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Total clearances
9
2020-11-20 → 2024-03-22
Last 12 months
0
Product codes
2
Most recent
2024-03-22
Name variants in FDA filings: Neuronetics / Neuronetics, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OBP Transcranial Magnetic Stimulator Class II Neurology 7 2024-03-22
QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder Class II Neurology 2 2023-06-08
Filings

All 510(k) clearances (9)

Date K-number Device Code Class Specialty
2024-03-22 K231926 NeuroStar Advanced Therapy System (All previously cleared models) OBP Class II Neurology
2023-12-13 K233621 NeuroStar Advanced Therapy System (Version 3.8) OBP Class II Neurology
2023-06-08 K231350 OCD MT Cap (85-00397-000) QCI Class II Neurology
2023-04-04 K230029 NeuroStar Advanced Therapy System (Version 3.7) OBP Class II Neurology
2022-08-24 K222230 NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health OBP Class II Neurology
2022-07-15 K220127 NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health OBP Class II Neurology
2022-05-06 K212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar QCI Class II Neurology
2021-12-10 K213543 NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health OBP Class II Neurology
2020-11-20 K201158 NeuroStar Advanced Therapy OBP Class II Neurology
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence