K-number	K231238
Device name	Ultravision2 System
Applicant	Alesi Surgical, Ltd.
Product code	PQM
Device class	Class II
Decision date	Oct 31, 2023
Decision	Substantially Equivalent
Regulation	878.5050

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Source

View the full FDA submission: accessdata.fda.gov

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Ultravision2 System

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Ultravision2 System