K-number	K182045
Device name	Lotus III Multi-Pulsed Er: Yag Laser System
Applicant	Laseroptek Co., Ltd.
Product code	GEX
Device class	Class II
Decision date	Dec 27, 2018
Decision	Substantially Equivalent
Regulation	878.4810

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View the full FDA submission: accessdata.fda.gov

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Lotus III Multi-Pulsed Er: Yag Laser System

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