Candela Corporation

FDA Device Registration & Listing · Marlborough, MA, US · Registration 3016496662

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016496662
FEI Number
3016496662
Entity Name
Candela Corporation
City/State/Country
Marlborough, MA, US
Establishment Address
251 Locke Drive, Marlborough, MA 01752, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Candela Corporation (Owner Number: 1218402)
Owner / Operator Contact Address
251 Locke Drive, --, Marlborough, MA 01752, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K240070
PMA Number
N/A

All Registered Proprietary Names

Celluma Pro C3 eTwo Celluma Pro C3 Velashape, Velashape II GentleYAG LE GentleYAG GentleYag Pro U Vbeam Pro Vbeam Prima Pro Vbeam Prima Vbeam Perfecta Nordlys, Nordlys Mini Picoway Laser System Nordlys (Ellipse Nordlys); Sirius; IPL; Nd:YAG Profound GentleMax Pro GentleMax Pro, GentleLase Pro U, GentleYag Pro U Gentle Pro Series Alex Trivantage Candela Q-Switched Alexandrite Laser AlexTrivantage GentleMax Pro Plus Glace GentleLase Pro GentleLase Pro LE GentleTouch The Gentle Family, Gentle Pro Series GentleMax Pro, GentleLase Pro U, GentleYag Pro U CO2RE, CO2RE Intima Profound Matrix Matrix

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLI Fat Reducing Low Level Laser General, Plastic Surgery Class 2 878.5400 2026-01-05
OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery Class 2 878.4810 2026-01-05
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2026-01-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-12-20
OLP Over-The-Counter Powered Light Based Laser For Acne General, Plastic Surgery Class 2 878.4810 2026-01-05
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2026-01-05
OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery Class 2 878.4810 2026-01-05
NUV Massager, Vacuum, Light Induced Heating General, Plastic Surgery Class 2 878.4810 2019-12-20
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-01-29
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-06-12
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-12-20
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-11-08
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2020-02-07
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-02-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-12-20
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2019-12-20
PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis General, Plastic Surgery Class 2 878.4810 2014-05-19
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2014-05-19
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2010-12-07
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-06-26
GFE Brush, Dermabrasion, Powered General, Plastic Surgery Class 1 878.4820 2025-03-07
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2014-11-10
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-12-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-07-03

Official Correspondent

Greg Wallender

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Candela Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016496662. Last updated year: 2026. Please use registration number 3016496662 when referencing this establishment in official correspondence.
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