K-number	K121031
Device name	WAVELIGHT FS200 PATIENT INTERFACE 1505
Applicant	Alcon Research, Ltd.
Product code	GEX
Device class	Class II
Decision date	Jun 21, 2012
Decision	Substantially Equivalent
Regulation	878.4810

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View the full FDA submission: accessdata.fda.gov

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WAVELIGHT FS200 PATIENT INTERFACE 1505

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