← DeviceClear
HomeDevice Clearances

PicoWay Laser System — Candela Corporation (510(k) K191685)

PicoWay Laser System — Candela Corporation (510(k) K191685) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: PicoWay Laser System; Applicant: Candela Corporation; Clearance track: 510(k).

Device namePicoWay Laser System
ApplicantCandela Corporation
Clearance track510(k)
Submission numberK191685
DecisionSubstantially Equivalent
Decision date2019-09-16
Date received2019-06-24
Product codeGEX
Device class2
Medical specialtyGeneral, Plastic Surgery
Applicant locationMA, US
SourceopenFDA device

🔍 Search all device clearances →