FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FAQ (102)
K Number: K240616
·
Decision Jul 15, 2024
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
11
Applicant Total
10
Review Days
132
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Basic Information
- Device Name
- FAQ (102)
- K Number
- K240616
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4420
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Foreo, Inc.
- Date Received
- March 5, 2024
- Decision Date
- July 15, 2024
- Product Code
- PAY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | FDA class 2 | General, Plastic Surgery |
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