K-number	K161480
Device name	R2 Dermal Cooling System
Applicant	R2 Dermatology
Product code	GEH
Device class	Class II
Decision date	Oct 5, 2016
Decision	Substantially Equivalent
Regulation	878.4350

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View the full FDA submission: accessdata.fda.gov

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R2 Dermal Cooling System

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