SculpSure
K-Number: K160470 · 2016-07-21
Device Summary
Frequently Asked Questions
What is the SculpSure?
SculpSure is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Cynosure, Inc.. The 510(k) number is K160470.
When did SculpSure receive FDA 510(k) clearance?
SculpSure received FDA 510(k) clearance on 2016-07-21, under 510(k) number K160470.
Who is the listed applicant for SculpSure?
The FDA 510(k) record lists Cynosure, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SculpSure?
The FDA product code for SculpSure is PKT.
Other records listing Cynosure, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: PKT)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.