Dermal Single- Use Cartridge 6-Pkg, Profound, KT76653

GUDID 00817495023892

Dermal Single- Use Cartridge 6-Pkg, Profound,

Candela Corporation

Multi-modality skin surface treatment system
Primary Device ID00817495023892
NIH Device Record Key9d79a33d-a358-4b92-91be-6bd984232f87
Commercial Distribution StatusIn Commercial Distribution
Brand NameDermal Single- Use Cartridge 6-Pkg, Profound,
Version Model NumberKT76653
Catalog NumberKT76653
Company DUNS053468385
Company NameCandela Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495023892 [Primary]
GS127290109950826 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-30
Device Publish Date2023-10-20

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00817495024639 - GYAG Pro U Laser System2024-10-02 GYAG Pro U Laser System
00817495024646 - Glase Pro U Laser System2024-10-02 Glase Pro U Laser System
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00817495024660 - GMAX Pro Plus Laser System2024-10-02 GMAX Pro Plus Laser System

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