Name: Predicase
Price: 199 USD

K-number	K122315
Device name	FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC
Applicant	Oculus Private Limited
Product code	LPL
Device class	Class II
Decision date	Feb 15, 2013
Decision	Substantially Equivalent
Regulation	886.5925

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Source

View the full FDA submission: accessdata.fda.gov

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FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC

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