FDA applicant
Syneron Candela Corporation
FDA records 7 decisions for Syneron Candela Corporation (Wayland, MA) from 2016 to 2018: 7 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and PBX (Massager, Vacuum, Radio Frequency Induced Heat). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 37 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Syneron-Candela”, “Syneron-Candela Corp”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Syneron Candela Corporation’s devices, and how often a recall has named them.
FDA decisions per year
2in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Syneron Candela Corporation’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.