FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SmoothCool HR System
K Number: K213484
·
Decision Apr 20, 2022
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
15
Review Days
173
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Basic Information
- Device Name
- SmoothCool HR System
- K Number
- K213484
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jeisys Medical, Inc.
- Date Received
- October 29, 2021
- Decision Date
- April 20, 2022
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Jeisys Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231216 | POTENZA | Dec 10, 2024 | Substantially Equivalent |
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| K230663 | Density | Aug 14, 2023 | Substantially Equivalent |
| K223685 | SmoothCool HR System | Jan 4, 2023 | Substantially Equivalent |
| K201685 | Potenza | Jan 19, 2021 | Substantially Equivalent |
| K183284 | INTRAcel RF Microneedle System | Jan 15, 2020 | Substantially Equivalent |
| K181896 | LIPOcel | Oct 18, 2019 | Substantially Equivalent |
| K162169 | EdgeOne CO2 Laser | Oct 27, 2016 | Substantially Equivalent |
| K153727 | INTRAcel Premium Fractional RF Micro Needle (FRM) System | Jul 21, 2016 | Substantially Equivalent |
| K142833 | INTRAGen | Jun 4, 2015 | Substantially Equivalent |