K-number	K192528
Device name	CO2 Laser Therapy System
Applicant	Shangdong Huamei Technology Co., Ltd.
Product code	GEX
Device class	Class II
Decision date	Dec 3, 2019
Decision	Substantially Equivalent
Regulation	878.4810

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View the full FDA submission: accessdata.fda.gov

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CO2 Laser Therapy System

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