K-number	K202601
Device name	Single-use Sterile medical laser fiber
Applicant	Realton (Suzhou) Medical Technology Co., Ltd.
Product code	GEX
Device class	Class II
Decision date	Dec 15, 2020
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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Single-use Sterile medical laser fiber

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