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FDA 510(k)

ULTRASHAPE POWER SYSTEM

K-Number: K160896 · 2016-07-08

ApplicantSyneron Medical, Ltd.
Decision Date2016-07-08
Product CodeOHV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRASHAPE POWER 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 2016-07-08 under 510(k) number K160896. 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 POWER SYSTEM?

ULTRASHAPE POWER SYSTEM is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Syneron Medical, Ltd.. The 510(k) number is K160896.

When did ULTRASHAPE POWER SYSTEM receive FDA 510(k) clearance?

ULTRASHAPE POWER SYSTEM received FDA 510(k) clearance on 2016-07-08, under 510(k) number K160896.

Who is the listed applicant for ULTRASHAPE POWER 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 POWER SYSTEM?

The FDA product code for ULTRASHAPE POWER 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 SystemK162163UltraShape SystemK161952UltraShape 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

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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