Name: Predicase
Price: 199 USD

K-number	K142510
Device name	UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens
Applicant	Synergeyes, Inc.
Product code	HQD
Device class	Class II
Decision date	Nov 19, 2014
Decision	Substantially Equivalent
Regulation	886.5916

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Source

View the full FDA submission: accessdata.fda.gov

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UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens

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