NeuroStar Advanced Therapy System (Version 3.8)— 510(k) K233621

Name: FDA 510(k) clearance K233621
Creator: U.S. Food and Drug Administration
Published: 2023-12-13

Substantially Equivalent

Neuronetics

FDA 510(k) clearance K233621 for NeuroStar Advanced Therapy System (Version 3.8), Substantially Equivalent on 2023-12-13. Applicant: Neuronetics. Device class: 2.

Clearance details

Applicant: Neuronetics
Product code: Code OBP
Device class: Class 2
Regulation: 21 CFR 882.5805
Advisory panel: Neurology
Date received: 2023-11-13
Decision date: 2023-12-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OBP

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K260396 — KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)2026-09-06
K260691 — BTL-6992026-08-23
K261228 — QuickVision Ultimate rTMS2026-08-14
K260189 — MagVenture Accelerated TMS (aTMS) Therapy System2026-05-22
K260560 — Apollo TMS Therapy System; Apollo light TMS Therapy System2026-05-22

More clearances from Neuronetics

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K231350 — OCD MT Cap (85-00397-000)2023-06-08
K230029 — NeuroStar Advanced Therapy System (Version 3.7)2023-04-04
K133408 — NEUROSTAR TMS THERAPY SYSTEM2014-03-28
K130233 — NEUROSTAR TMS THERAPY SYSTEM2013-04-30
K083538 — NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.12008-12-16

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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