FDA applicant
Syneron Beauty, Ltd.
FDA records 4 decisions for Syneron Beauty, Ltd. (Philedelphia, PA) from 2012 to 2013: 4 510(k) clearances. Most are in product codes ONF (Powered Light Based Non-Laser Surgical…) and OLP (Over-The-Counter Powered Light Based Laser For…). Its devices cite 10 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Syneron Beauty”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Syneron Beauty, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2013
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Syneron Beauty, 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.