K243780
- 510(k) number
- K243780
- Device name
- HELIOS 785 Pico (1754V2)
- Applicant
- Laseroptek Co., Ltd. KR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-02-07
- Date received
- 2024-12-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243780.pdf
Official FDA record: K243780
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.