GentleMax Pro

GUDID 00817495020013

Pulsed Laser

CANDELA CORPORATION

Dermatological solid-state laser system
Primary Device ID00817495020013
NIH Device Record Key7621b06d-918f-41f6-a405-c7172641d82c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleMax Pro
Version Model Number9914-00-9035
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495020013 [Primary]
GS108174950200017 [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 Date2020-05-13
Device Publish Date2016-09-23

On-Brand Devices [GentleMax Pro ]

08174950200970Pulsed Laser
08174950200963Pulsed Laser
08174950200956Pulsed Laser
08174950200277Pulsed Laser
08174950200017Pulsed Laser
00817495020013Pulsed Laser
00817495020976Pulsed Laser
00817495020969Pulsed Laser
00817495020952Pulsed Laser
00817495020273Pulsed Laser

Trademark Results [GentleMax Pro]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GENTLEMAX PRO
GENTLEMAX PRO
85239469 4143836 Live/Registered
Candela Corporation
2011-02-10

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