K253344
- 510(k) number
- K253344
- Device name
- BELLUS-Q
- Applicant
- Speclipse, Inc. KR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-11-25
- 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: K253344.pdf
Official FDA record: K253344
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.