K-number	K191349
Device name	980nm Diode Laser Therapy Device
Applicant	Shanghai Apolo Medical Technology Co., Ltd.
Product code	GEX
Device class	Class II
Decision date	Aug 16, 2019
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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980nm Diode Laser Therapy Device

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