FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
LED Phototherapy Device
K Number: K162098
·
Decision Jan 30, 2017
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
50
Applicant Total
3
Review Days
185
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Basic Information
- Device Name
- LED Phototherapy Device
- K Number
- K162098
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Li-Tek Electronic Technology Corporation
- Date Received
- July 29, 2016
- Decision Date
- January 30, 2017
- Product Code
- OLP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OLP | Over-The-Counter Powered Light Based Laser For Acne | FDA class 2 | General, Plastic Surgery |
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