SMILE
FDA 510(k) clearance K213629 · decided 2023-02-12
Clearance details
- K-number
- K213629
- Device name
- SMILE
- Applicant
- Nu Eyne Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-11-17
- Decision date
- 2023-02-12
- Days to decision
- 452 days
- Clearance type
- Traditional
- Product code
- QGL
- Device class
- 2
- Regulation number
- 882.5898
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Seoul, KR
- 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 |
| Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® (K233293) | Neurosigma, Inc. | 2024-01-16 |
| Monarch eTNS System (DEN180041) | Neurosigma, Inc. | 2019-04-19 |
Recalls involving this device
No recalls on record reference this clearance.