GYAG Pro U Laser System

GUDID 00817495023656

GYAG Pro U Laser System

Candela Corporation

Dermatological solid-state laser system
Primary Device ID00817495023656
NIH Device Record Keya13dff45-cbdf-47e5-999a-ec6c4edf6363
Commercial Distribution Discontinuation2024-10-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGYAG Pro U Laser System
Version Model Number9914-CH-9020
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495023656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-10-15
Device Publish Date2022-12-16

On-Brand Devices [GYAG Pro U Laser System]

00817495024639GYAG Pro U Laser System
00817495023656GYAG Pro U Laser System

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