FDA applicant
Syneron Medical, Ltd.
FDA records 35 decisions for Syneron Medical, Ltd. (Yokneam Illit, IL) from 2002 to 2017: 35 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and OHV (Focused Ultrasound For Tissue Heat Or…). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 82 predicates, 33 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 Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Syneron Medical, 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.