K-number	K220516
Device name	CATALYS Precision Laser system
Applicant	Amo Manufacturing USA, LLC
Product code	OOE
Device class	Class II
Decision date	May 17, 2022
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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