FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
LIPOcel
K Number: K181896
·
Decision Oct 18, 2019
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
29
Applicant Total
15
Review Days
459
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Basic Information
- Device Name
- LIPOcel
- K Number
- K181896
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4590
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jeisys Medical, Inc.
- Date Received
- July 16, 2018
- Decision Date
- October 18, 2019
- Product Code
- OHV
- 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 |
|---|---|---|---|
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | FDA class 2 | General, Plastic Surgery |
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