FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
K Number: K222230
·
Decision Aug 24, 2022
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
65
Applicant Total
8
Review Days
30
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Basic Information
- Device Name
- NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
- K Number
- K222230
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5805
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuronetics, Inc.
- Date Received
- July 25, 2022
- Decision Date
- August 24, 2022
- Product Code
- OBP
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OBP), ordered by most recent decision date.
MagVenture Accelerated TMS (aTMS) Therapy System
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BrainsWay Deep TMS System
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Other Clearances by Neuronetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Mar 22, 2024 | Substantially Equivalent |
| K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health | Jul 15, 2022 | Substantially Equivalent |
| K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar | May 6, 2022 | Substantially Equivalent |
| K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health | Dec 10, 2021 | Substantially Equivalent |
| K201158 | NeuroStar Advanced Therapy | Nov 20, 2020 | Substantially Equivalent |
| K161519 | NeuroStar TMS Therapy System | Sep 11, 2016 | Substantially Equivalent |
| K160703 | NeuroStar TMS Therapy System | Jun 10, 2016 | Substantially Equivalent |