FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Silk'n Titan Allways
K Number: K230013
·
Decision Aug 30, 2023
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
11
Applicant Total
1
Review Days
239
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Basic Information
- Device Name
- Silk'n Titan Allways
- K Number
- K230013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4420
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Silk'N Beauty , Ltd.
- Date Received
- January 3, 2023
- Decision Date
- August 30, 2023
- Product Code
- PAY
- 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 |
|---|---|---|---|
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | FDA class 2 | General, Plastic Surgery |
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