K253114
- 510(k) number
- K253114
- Device name
- TargetCool (RM-DT02W)
- Applicant
- Recensmedical, Inc. KR
- Product code
- GEH — Unit, Cryosurgical, Accessories
- Decision date
- 2025-10-16
- Date received
- 2025-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K253114.pdf
Official FDA record: K253114
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.