Name: Predicase
Price: 199 USD

K-number	K180402
Device name	PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
Applicant	Topcon Medical Laser Systems, Inc.
Product code	HQF
Device class	Class II
Decision date	May 25, 2018
Decision	Substantially Equivalent
Regulation	886.4390

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Source

View the full FDA submission: accessdata.fda.gov

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PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar

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