FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
CurrentBody Skin RF
K Number: K232424
·
Decision Mar 6, 2024
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
11
Applicant Total
12
Review Days
208
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Basic Information
- Device Name
- CurrentBody Skin RF
- K Number
- K232424
- 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
- El Global Trade, Ltd.
- Date Received
- August 11, 2023
- Decision Date
- March 6, 2024
- 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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Other Clearances by El Global Trade, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252621 | DeepSkin (DEP100) | May 8, 2026 | Substantially Equivalent |
| K250341 | Sensilift Pro (ST300XXYYZZZ) | Jan 6, 2026 | Substantially Equivalent |
| K250384 | IPL400 | May 23, 2025 | Substantially Equivalent |
| K183260 | Sensilight Pro / Pistol IPL | Mar 18, 2019 | Substantially Equivalent |
| K181095 | RF-Relief | Jul 24, 2018 | Substantially Equivalent |
| K172181 | micro IPL | Oct 13, 2017 | Substantially Equivalent |
| K170637 | sensiFirm | Jul 14, 2017 | Substantially Equivalent |
| K170499 | sensiLift | Jun 15, 2017 | Substantially Equivalent |
| K161089 | sensiLight Mini | Jul 8, 2016 | Substantially Equivalent |
| K140381 | SENSILIGHT/ SENSILIGHT PLUS | Aug 8, 2014 | Substantially Equivalent |