GentleMax Delivery System

GUDID 00817495022109

Delivery System Assembly

CANDELA CORPORATION

Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator
Primary Device ID00817495022109
NIH Device Record Key64c9af85-a791-47fa-96ff-17355945a916
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleMax Delivery System
Version Model Number0800-00-1080
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS100817495022109 [Primary]
GS108174950202103 [Previous]
GS108174950202103 [Previous]
GS108174950202103 [Previous]
GS108174950202103 [Previous]
GS108174950202103 [Previous]
GS108174950202103 [Previous]
GS108174950202103 [Previous]
GS108174950202103 [Previous]
GS108174950202103 [Previous]
GS108174950202103 [Previous]
GS108174950202103 [Previous]
GS108174950202103 [Previous]
GS108174950202103 [Previous]
GS108174950202103 [Previous]
GS108174950202103 [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 Number4
Public Version Date2020-06-17
Device Publish Date2016-09-23

Devices Manufactured by CANDELA CORPORATION

08174950202202 - Cbeam 10MM Handpiece Assembly2020-07-01 Handpiece Assembly
08174950202219 - Cbeam 5MM Handpiece Assembly2020-07-01 Handpiece Assembly
08174950202226 - Cbeam 7MM Handpiece Assembly2020-07-01 Handpiece Assembly
00817495020181 - GentleMax2020-07-01 Pulsed Laser
00817495020198 - GentleMax2020-07-01 Pulsed Laser
00817495020211 - GentleLASE2020-07-01 Pulsed Laser
00817495020037 - PicoWay2020-06-30 Pulsed Laser
00817495020433 - Vbeam 2020-06-30 Pulsed Laser

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