K253750
- 510(k) number
- K253750
- Device name
- BTL-785NEH
- Applicant
- BTL Industries, Inc. MA · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-03-17
- Date received
- 2025-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K253750.pdf
Official FDA record: K253750
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.