FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
TargetCool
K Number: K230599
·
Decision Jun 22, 2023
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
7
Review Days
111
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Basic Information
- Device Name
- TargetCool
- K Number
- K230599
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Recensmedical, Inc.
- Date Received
- March 3, 2023
- Decision Date
- June 22, 2023
- Product Code
- GEH
- 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 |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Recensmedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253114 | TargetCool (RM-DT02W) | Oct 16, 2025 | Substantially Equivalent |
| K253348 | TargetCool-e | Oct 15, 2025 | Substantially Equivalent |
| DEN230011 | OcuCool | Sep 30, 2024 | Unknown |
| K221234 | TargetCool | Jul 22, 2022 | Substantially Equivalent |
| K220674 | TargetCool | Mar 31, 2022 | Substantially Equivalent |
| K203481 | CryoVIVE | May 13, 2021 | Substantially Equivalent |