FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SMILE
K Number: K213629
·
Decision Feb 12, 2023
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
4
Applicant Total
5
Review Days
452
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Basic Information
- Device Name
- SMILE
- K Number
- K213629
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5898
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nu Eyne Co., Ltd.
- Date Received
- November 17, 2021
- Decision Date
- February 12, 2023
- Product Code
- QGL
- 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 |
|---|---|---|---|
| QGL | Transcutaneous Nerve Stimulator For Adhd | FDA class 2 | Neurology |
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