K261214
- 510(k) number
- K261214
- Device name
- PICO SHINING (PICO-K; PICOFY)
- Applicant
- Speclipse, Inc. KR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-05-11
- Date received
- 2026-04-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K261214.pdf
Official FDA record: K261214
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.