FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SmoothCool HR System
K Number: K223685
·
Decision Jan 4, 2023
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
15
Review Days
26
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SmoothCool HR System
- K Number
- K223685
- 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
- December 9, 2022
- Decision Date
- January 4, 2023
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PICOSURE WORKSTATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LumiGlam Laser System (SHE-LSP601-3)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LASEmaR 1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUNE PureHygiene
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Boston 2910 (Boston 2910)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Jeisys Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231216 | POTENZA | Dec 10, 2024 | Substantially Equivalent |
| K231287 | POTENZA | Nov 5, 2024 | Substantially Equivalent |
| K230663 | Density | Aug 14, 2023 | Substantially Equivalent |
| K213484 | SmoothCool HR System | Apr 20, 2022 | 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 |