GentleLase Pro

GUDID 00817495022024

Pulsed Laser

Candela Corporation

Dermatological solid-state laser system
Primary Device ID00817495022024
NIH Device Record Key4484be31-2496-48f6-946b-21f7134942bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleLase Pro
Version Model Number9914-00-9330
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495022024 [Primary]
GS108174950202028 [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 Number6
Public Version Date2022-10-12
Device Publish Date2016-09-23

On-Brand Devices [GentleLase Pro ]

08174950202028Pulsed Laser
08174950201823Pulsed Laser
08174950201816Pulsed Laser
08174950200888Pulsed Laser
08174950200871Pulsed Laser
08174950200376Pulsed Laser
08174950200338Pulsed Laser
08174950200079Pulsed Laser
00817495020075Pulsed Laser
00817495020372Pulsed Laser
00817495020334Pulsed Laser
00817495020884Pulsed Laser
00817495020877Pulsed Laser
00817495022024Pulsed Laser
00817495021829Pulsed Laser
00817495021812Pulsed Laser

Trademark Results [GentleLase Pro]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GENTLELASE PRO
GENTLELASE PRO
85239530 4092264 Live/Registered
Candela Corporation
2011-02-10

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