Name: Predicase
Price: 199 USD

K-number	K170121
Device name	Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
Applicant	Lumenis, Ltd.
Product code	GEX
Device class	Class II
Decision date	May 22, 2017
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories

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