GentleLASE Limited Edition

GUDID 00817495020778

Pulsed Laser

CANDELA CORPORATION

Dermatological solid-state laser system
Primary Device ID00817495020778
NIH Device Record Key8778ee8c-07f3-48fa-89f6-c11a192e9b3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleLASE Limited Edition
Version Model Number9914-12-0910
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
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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495020778 [Primary]
GS108174950200772 [Previous]

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 Number5
Public Version Date2020-06-11
Device Publish Date2016-09-23

On-Brand Devices [GentleLASE Limited Edition]

08174950200789Pulsed Laser
08174950200772Pulsed Laser
08174950200765Pulsed Laser
08174950200109Pulsed Laser
00817495020105Pulsed Laser
00817495020785Pulsed Laser
00817495020778Pulsed Laser
00817495020761Pulsed Laser

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