FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Powersculp laser lipolysis system
K Number: K211402
·
Decision Jul 30, 2021
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
18
Applicant Total
2
Review Days
85
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Basic Information
- Device Name
- Powersculp laser lipolysis system
- K Number
- K211402
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lotuxs Medtech (Suzhou) Co., Ltd.
- Date Received
- May 6, 2021
- Decision Date
- July 30, 2021
- Product Code
- PKT
- 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 |
|---|---|---|---|
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Lotuxs Medtech (Suzhou) Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K222862 | SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC | Jul 30, 2023 | Substantially Equivalent |