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FDA 510(k)

SculpSure

K-Number: K160470 · 2016-07-21

ApplicantCynosure, Inc.
Decision Date2016-07-21
Product CodePKT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SculpSure is a medical device manufactured by Cynosure, Inc.. It received FDA 510(k) clearance on 2016-07-21 under approval number K160470. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SculpSure?

SculpSure is a medical device that received FDA 510(k) clearance on 2016-07-21. It is manufactured by Cynosure, Inc.. The 510(k) number is K160470.

When was SculpSure approved by the FDA?

SculpSure received FDA 510(k) clearance on 2016-07-21, under approval number K160470.

What company makes SculpSure?

SculpSure is manufactured by Cynosure, Inc..

What is the FDA product code for SculpSure?

The FDA product code for SculpSure is PKT.

Other Devices by Cynosure, Inc.

K160480PicoSure Workstation K171992SculpSure K171262TempSure K171111Sculpsure K182365TempSure System K173199PicoSure Workstation

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Related Devices (Code: PKT)

K171992SculpSureCynosure, Inc. K171111SculpsureCynosure, Inc. K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd. K180511Eon FRDominion Aesthetic Technologies, Inc. K182741SculpSureCynosure K192970SLIMUSHironic Co., 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.

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