FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
1060nm laser body slimming machine
K Number: K240658
·
Decision May 13, 2024
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
18
Applicant Total
3
Review Days
66
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Basic Information
- Device Name
- 1060nm laser body slimming machine
- K Number
- K240658
- 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
- Hebei JT Medical Co., Ltd.
- Date Received
- March 8, 2024
- Decision Date
- May 13, 2024
- 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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