Name: Predicase
Price: 199 USD

K-number	K202241
Device name	LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
Applicant	Hamilton Thorne, Inc.
Product code	MRX
Device class	Class II
Decision date	Jul 2, 2021
Decision	Substantially Equivalent
Regulation	884.6200

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Source

View the full FDA submission: accessdata.fda.gov

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LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)

Everything you need for a 510(k) submission. Nothing you don't.