K-number	K192617
Device name	Gemini 810+980 Soft Tissue Laser
Applicant	Azena Medical, LLC
Product code	GEX
Device class	Class II
Decision date	Feb 20, 2020
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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Gemini 810+980 Soft Tissue Laser

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