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FDA 510(k)

UltraShape System

K-Number: K162163 · 2016-11-17

ApplicantSyneron Medical, Ltd.
Decision Date2016-11-17
Product CodeOHV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UltraShape System is the device name listed in this FDA 510(k) record. The listed applicant is Syneron Medical, Ltd.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162163. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraShape System?

UltraShape System is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Syneron Medical, Ltd.. The 510(k) number is K162163.

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

UltraShape System received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162163.

Who is the listed applicant for UltraShape System?

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

What is the FDA product code for UltraShape System?

The FDA product code for UltraShape System is OHV.

Other records listing Syneron Medical, Ltd. 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.

K170370ULTRASHAPE POWER SYSTEMK163415SlimShape SystemK161952UltraShape SystemK160896ULTRASHAPE POWER SYSTEM

Related Devices (Code: OHV)

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.

K260618Ulthera® SystemUlthera, Inc.K250418Ulthera System (UC-1 Control Unit PRIME Model 2.1)Ulthera, Inc.K243035Ulthera® SystemUlthera, Inc.K240687SofWave SystemSofwave Medical, Ltd.K233996Ulthera System (UC-1 Control Unit PRIME)Ulthera, Inc.K233104SofWave SystemSofwave Medical, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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