K-number	K223838
Device name	Catalys Precision Laser System
Applicant	Amo Manufacturing USA, LLC
Product code	OOE
Device class	Class II
Decision date	Apr 12, 2023
Decision	Substantially Equivalent
Regulation	886.4390

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Source

View the full FDA submission: accessdata.fda.gov

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Catalys Precision Laser System

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Catalys Precision Laser System