K230100
- 510(k) number
- K230100
- Device name
- SCIZER (SC1-M410)
- Applicant
- Classys, Inc. KR
- Product code
- OHV — Focused Ultrasound For Tissue Heat Or Mechanical Cel
- Decision date
- 2023-11-03
- Date received
- 2023-01-13
- 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: K230100.pdf
Official FDA record: K230100
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.