Name: Predicase
Price: 199 USD

K-number	K223566
Device name	ELITA Femtosecond Laser System, ELITA Patient Interface
Applicant	Johnson & Johnson Surgical Vision, Inc.
Product code	OOE
Device class	Class II
Decision date	Apr 14, 2023
Decision	Substantially Equivalent
Regulation	886.4390

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Source

View the full FDA submission: accessdata.fda.gov

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ELITA Femtosecond Laser System, ELITA Patient Interface

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

ELITA Femtosecond Laser System, ELITA Patient Interface