FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Smart Photon Micro-current Device, Model: EP-300
K Number: K162652
·
Decision Oct 25, 2017
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
77
Applicant Total
3
Review Days
397
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Smart Photon Micro-current Device, Model: EP-300
- K Number
- K162652
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Li-Tek Electronic Technology Corporation
- Date Received
- September 23, 2016
- Decision Date
- October 25, 2017
- Product Code
- NFO
- 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 |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NFO), ordered by most recent decision date.
VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
FDA 510(k)
FDA Class 2
·Neurology
Ulike Clear Zero (YC10 BU)
FDA 510(k)
FDA Class 2
·Neurology
DeepSkin (DEP100)
FDA 510(k)
FDA Class 2
·Neurology
Aura Glide (FC40)
FDA 510(k)
FDA Class 2
·Neurology
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
FDA 510(k)
FDA Class 2
·Neurology
Medi Lift Essential Eye Mask
FDA 510(k)
FDA Class 2
·Neurology