Name: Predicase
Price: 199 USD

K-number	K170409
Device name	PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
Applicant	Topcon Medical Laser Systems, Inc. (Tmls)
Product code	GEX
Device class	Class II
Decision date	Sep 12, 2017
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System

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