Data / Medical devices / United States / Candela Corporation

Candela Corporation: FDA-registered device maker in Marlborough, MA, United States, 17 510(k) clearances

Name: Candela Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Candela Corporation is registered with the FDA (registration 3016496662) in Marlborough, MA, United States. It lists 11 device types. The FDA files 17 510(k) clearances under its listings, the newest dated July 1, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016496662
Address: 251 Locke Drive, Marlborough, MA, United States, 01752
Owner or operator: Candela Corporation (1218402)
Roles: Complaint file establishment, Specification developer
First device listed: January 25, 2008
Registered through: 2026
Brand names listed: CO2RE, CO2RE Intima, Celluma Pro C3, Dynamic Cooling, Elos Plus, Gentle Pro Series, GentleLase Pro, GentleLase Pro LE, GentleMax Pro and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Fat Reducing Low Level Laser	OLI	2	Complaint file establishment	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Complaint file establishment	accessdata.fda.gov
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis	PDZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Light Based Over The Counter Wrinkle Reduction	OHS	2	Complaint file establishment	accessdata.fda.gov
Massager, Vacuum, Light Induced Heating	NUV	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Complaint file establishment	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 1, 2024	K240070	Profound Matrix	GEI	Substantially Equivalent	Candela Corporation	accessdata.fda.gov
November 21, 2023	K232977	Biophotas Celluma CONTOUR	OLI	Substantially Equivalent	Biophotas, Inc.	accessdata.fda.gov
June 1, 2023	K230990	Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)	GEX	Substantially Equivalent	Candela Corporation	accessdata.fda.gov
October 13, 2022	K220853	PicoWay Laser System	GEX	Substantially Equivalent	Candela Corporation	accessdata.fda.gov
December 20, 2021	K212492	Frax 1940 for Nordlys and Frax Pro	GEX	Substantially Equivalent	Candela Corporation	accessdata.fda.gov
May 26, 2020	K201111	GentleMax Pro Plus	GEX	Substantially Equivalent	Candela Corporation	accessdata.fda.gov
July 11, 2018	K181523	Syneron CO2RE System	GEX	Substantially Equivalent	Syneron-Candela Corp	accessdata.fda.gov
September 12, 2016	K161043	Profound System	PBX	Substantially Equivalent	Syneron Candela Corporation	accessdata.fda.gov
March 2, 2016	K152280	BioPhotas Celluma3	ILY	Substantially Equivalent	Biophotas, Inc.	accessdata.fda.gov
July 7, 2015	K150907	Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra	GEX	Substantially Equivalent	Ellipse A/S	accessdata.fda.gov
December 8, 2014	K141507	TWO SKIN TREATMENT SYSTEM	GEI	Substantially Equivalent	Syneron Medical, Ltd.	accessdata.fda.gov
November 7, 2014	K140732	CANDELA GENTLELASE FAMILY OF LASER SYSTEMS	GEX	Substantially Equivalent	Candela Corp.	accessdata.fda.gov
May 9, 2014	K140122	CANDELA GENTLEMAX FAMILY OF LASER SYSTEM	GEX	Substantially Equivalent	Candela Corp.	accessdata.fda.gov
September 13, 2012	K122579	VELASHAPE	NUV	Substantially Equivalent	Syneron Medical, Ltd.	accessdata.fda.gov
June 11, 2012	K113868	EPLUS SKIN TREATMENT SYSTEM	GEX	Substantially Equivalent	Syneron, Ltd.	accessdata.fda.gov
October 30, 2003	K033172	CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS	GEX	Substantially Equivalent	Candela Corp.	accessdata.fda.gov
August 18, 2000	K001589	CANDELA DYNAMIC COOLING DEVICE	GEX	Substantially Equivalent	Candela Corp.	accessdata.fda.gov

Compare with other makers

Updated July 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.