Profound System
K-Number: K161043 · 2016-09-12
ApplicantSyneron Candela Corporation
Decision Date2016-09-12
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Profound System is a medical device manufactured by Syneron Candela Corporation. It received FDA 510(k) clearance on 2016-09-12 under approval number K161043. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Profound System?
Profound System is a medical device that received FDA 510(k) clearance on 2016-09-12. It is manufactured by Syneron Candela Corporation. The 510(k) number is K161043.
When was Profound System approved by the FDA?
Profound System received FDA 510(k) clearance on 2016-09-12, under approval number K161043.
What company makes Profound System?
Profound System is manufactured by Syneron Candela Corporation.
What is the FDA product code for Profound System?
The FDA product code for Profound System is PBX.
Related Clinical Trials
Other Devices by Syneron Candela Corporation
Related Devices (Code: PBX)
K162512truSculptCutera, Inc.
K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc.
K161551TR-100BTL Industries, Inc.
K160329InMode System MiniFX HandpieceInmode MD , Ltd.
K161199EndyMed Contour HandpieceEndymed Medical, Ltd.
K153568InMode Plus SystemInmode MD , Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.