Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
FDA 510(k) clearance K233293 · decided 2024-01-16
Clearance details
- K-number
- K233293
- Device name
- Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
- Applicant
- Neurosigma, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-29
- Decision date
- 2024-01-16
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- QGL
- Device class
- 2
- Regulation number
- 882.5898
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ADDNOX (BPSPM1) (K243289) | Nu Eyne Co., Ltd. | 2025-01-16 |
| BT-1000 (K232991) | Bistos Co., Ltd. | 2024-08-28 |
| SMILE (K213629) | Nu Eyne Co., Ltd. | 2023-02-12 |
| Monarch eTNS System (DEN180041) | Neurosigma, Inc. | 2019-04-19 |
Recalls involving this device
No recalls on record reference this clearance.