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FDA 510(k)

Ulthera System (UC-1 Control Unit PRIME)

K-Number: K233996 · 2024-02-22

ApplicantUlthera, Inc.
Decision Date2024-02-22
Product CodeOHV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ulthera System (UC-1 Control Unit PRIME) is the device name listed in this FDA 510(k) record. The listed applicant is Ulthera, Inc.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K233996. 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 (UC-1 Control Unit PRIME)?

Ulthera System (UC-1 Control Unit PRIME) is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Ulthera, Inc.. The 510(k) number is K233996.

When did Ulthera System (UC-1 Control Unit PRIME) receive FDA 510(k) clearance?

Ulthera System (UC-1 Control Unit PRIME) received FDA 510(k) clearance on 2024-02-22, under 510(k) number K233996.

Who is the listed applicant for Ulthera System (UC-1 Control Unit PRIME)?

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 (UC-1 Control Unit PRIME)?

The FDA product code for Ulthera System (UC-1 Control Unit PRIME) 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® SystemK192185The Cellfina SystemK180623Ulthera 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.K233104SofWave SystemSofwave Medical, Ltd.K232455SofWave 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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