K-number	K233996
Device name	Ulthera System (UC-1 Control Unit PRIME)
Applicant	Ulthera, Inc.
Product code	OHV
Device class	Class II
Decision date	Feb 22, 2024
Decision	Substantially Equivalent
Regulation	878.4590

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View the full FDA submission: accessdata.fda.gov

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Ulthera System (UC-1 Control Unit PRIME)

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