K242946
- 510(k) number
- K242946
- Device name
- HESTIA (L200-A)
- Applicant
- Senbitec Co., Ltd. KR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-10-03
- Date received
- 2024-09-25
- 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: K242946.pdf
Official FDA record: K242946
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.