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FDA 510(k)

The Cellfina System

K-Number: K192185 · 2019-10-09

ApplicantUlthera, Inc.
Decision Date2019-10-09
Product CodeOUP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

The Cellfina System is a medical device manufactured by Ulthera, Inc.. It received FDA 510(k) clearance on 2019-10-09 under approval number K192185. The device is classified under product code OUP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Cellfina System?

The Cellfina System is a medical device that received FDA 510(k) clearance on 2019-10-09. It is manufactured by Ulthera, Inc.. The 510(k) number is K192185.

When was The Cellfina System approved by the FDA?

The Cellfina System received FDA 510(k) clearance on 2019-10-09, under approval number K192185.

What company makes The Cellfina System?

The Cellfina System is manufactured by Ulthera, Inc..

What is the FDA product code for The Cellfina System?

The FDA product code for The Cellfina System is OUP.

Other Devices by Ulthera, Inc.

K161885The Cellfina System K153677The Cellfina System K180623Ulthera System K233996Ulthera System (UC-1 Control Unit PRIME) K250418Ulthera System (UC-1 Control Unit PRIME Model 2.1) K243035Ulthera® System

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Related Devices (Code: OUP)

K161885The Cellfina SystemUlthera, Inc. K153677The Cellfina SystemUlthera, Inc. K212399AveliNc8, Inc. K221336AvéliRevelle Aesthetics, Inc. K232153AvéliRevelle Aesthetics, Inc.

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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