FDA Device Entity Profile: Candela Corporation

Known Identifiers & Locations

FEI Numbers 3016496662

Owner Operator Numbers 1218402

Locations Covered Marlborough, MA, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3016496662	Candela Corporation	Marlborough, MA, US	Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K201111	GentleMax Pro Plus	2020-05-26	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

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