FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASERlipo System
K Number: K190551
·
Decision May 1, 2019
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
57
Applicant Total
5
Review Days
57
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Basic Information
- Device Name
- VASERlipo System
- K Number
- K190551
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Solta Medical
- Date Received
- March 5, 2019
- Decision Date
- May 1, 2019
- Product Code
- QPB
- 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 |
|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Solta Medical
| K Number | Device Name | ||
|---|---|---|---|
| K242142 | Fraxel® FTX Laser System | Aug 21, 2024 | Substantially Equivalent |
| K190555 | PowerX Lipo System | May 1, 2019 | Substantially Equivalent |
| K173759 | Thermage CPT System and Accessories | Jan 8, 2018 | Substantially Equivalent |
| K170758 | Thermage FLX System and Accessories | Sep 22, 2017 | Substantially Equivalent |