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Syneron Candela Corporation

FDA Regulatory Profile

Syneron Candela Corporation has 0 FDA recalls, 0 inspections, 7 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Jul 11, 2018

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances7Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K181523Syneron CO2RE SystemJul 11, 2018
K180593Vbeam Prima Laser SystemJun 5, 2018
K170597PicoWay Laser SystemMay 25, 2017
K162454PicoWay Laser SystemFeb 1, 2017
K161043Profound SystemSep 12, 2016
K160607PicoWay Laser SystemJul 5, 2016
K153527PicoWay Laser SystemMar 2, 2016

FDA data resources