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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Syneron Candela Corporation. It received FDA 510(k) clearance on 2016-09-12 under 510(k) 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. The listed applicant is Syneron Candela Corporation. The 510(k) number is K161043.

When did Profound System receive FDA 510(k) clearance?

Profound System received FDA 510(k) clearance on 2016-09-12, under 510(k) number K161043.

Who is the listed applicant for Profound System?

The FDA 510(k) record lists Syneron Candela Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Profound System?

The FDA product code for Profound System is PBX.

Other records listing Syneron Candela Corporation as applicant

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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.

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