K253348
- 510(k) number
- K253348
- Device name
- TargetCool-e
- Applicant
- Recensmedical, Inc. KR
- Product code
- GEH — Unit, Cryosurgical, Accessories
- Decision date
- 2025-10-15
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253348.pdf
Official FDA record: K253348
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.