The Cellfina System
K-Number: K153677 · 2016-02-25
ApplicantUlthera, Inc.
Decision Date2016-02-25
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 2016-02-25 under approval number K153677. 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 2016-02-25. It is manufactured by Ulthera, Inc.. The 510(k) number is K153677.
When was The Cellfina System approved by the FDA?
The Cellfina System received FDA 510(k) clearance on 2016-02-25, under approval number K153677.
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.
Related Devices (Code: OUP)
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.