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FDA 510(k)

Ulthera System

K-Number: K180623 · 2018-05-04

ApplicantUlthera, Inc.
Decision Date2018-05-04
Product CodeOHV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ulthera System is the device name listed in this FDA 510(k) record. The listed applicant is Ulthera, Inc.. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K180623. 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 Ulthera System?

Ulthera System is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Ulthera, Inc.. The 510(k) number is K180623.

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

Ulthera System received FDA 510(k) clearance on 2018-05-04, under 510(k) number K180623.

Who is the listed applicant for Ulthera System?

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

What is the FDA product code for Ulthera System?

The FDA product code for Ulthera System is OHV.

Other records listing Ulthera, 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.

K260618Ulthera® SystemK250418Ulthera System (UC-1 Control Unit PRIME Model 2.1)K243035Ulthera® SystemK233996Ulthera System (UC-1 Control Unit PRIME)K192185The Cellfina SystemK161885The Cellfina System

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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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