FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
AF Laser
K Number: K221363
·
Decision Jul 20, 2022
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
18
Applicant Total
11
Review Days
70
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Basic Information
- Device Name
- AF Laser
- K Number
- K221363
- 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
- ShenB Co., Ltd.
- Date Received
- May 11, 2022
- Decision Date
- July 20, 2022
- Product Code
- PDZ
- 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 |
|---|---|---|---|
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | FDA class 2 | General, Plastic Surgery |
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