FDA applicant
Syneron, Ltd.
FDA records 2 decisions for Syneron, Ltd. (Binyamina, IL) from 2011 to 2012: 2 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 12 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Syneron, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Syneron, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Syneron”
FDA records each applicant name separately; these may or may not be the same firm.