K250742
- 510(k) number
- K250742
- Device name
- Focused Cryotherapy System
- Applicant
- Focused Cryo, Inc. GA · US
- Product code
- GEH — Unit, Cryosurgical, Accessories
- Decision date
- 2025-12-09
- Date received
- 2025-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250742.pdf
Official FDA record: K250742
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.