GentleLase

GUDID 00817495022703

Pulsed Laser

CANDELA CORPORATION

Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system
Primary Device ID00817495022703
NIH Device Record Key7c3ab31a-f11c-4c7c-8b87-ceec98ed77a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleLase
Version Model Number9914-03-0883
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

Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS100817495022703 [Primary]
GS108174950202707 [Previous]
GS108174950202707 [Previous]
GS108174950202707 [Previous]
GS108174950202707 [Previous]
GS108174950202707 [Previous]
GS108174950202707 [Previous]
GS108174950202707 [Previous]
GS108174950202707 [Previous]
GS108174950202707 [Previous]
GS108174950202707 [Previous]
GS108174950202707 [Previous]
GS108174950202707 [Previous]
GS108174950202707 [Previous]
GS108174950202707 [Previous]
GS108174950202707 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
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 Date2020-06-23
Device Publish Date2016-12-13

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00817495022703Pulsed Laser

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