GentleMax Delivery System

GUDID 00817495022109

Delivery System Assembly

CANDELA CORPORATION

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]
GS108174950202103 [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 Number4
Public Version Date2020-06-17
Device Publish Date2016-09-23

Devices Manufactured by CANDELA CORPORATION

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00817495024028 - ASSY, DCD HAND PIECE, LARGE SPOT, GMPP2024-09-05 ASSY, DCD HAND PIECE, LARGE SPOT, GMPP
00817495024035 - GMPP DCD Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly2024-09-05 GMPP DCD Large Spot
00817495024042 - GMPP ACC Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly2024-09-05 GMPP ACC Large Spot
00817495024011 - MSDS DCD Option Kit GMPP2024-07-04 MSDS DCD Option Kit GMPP
00817495023946 - Modified LSDS Fiber Assembly, 12-26 mm2024-06-25 Modified LSDS Fiber Assembly 12-26 mm
00817495023984 - GentleCool Pro Canister Cryogen (R134a / 980g / US)2024-05-31 Canister Cryogen (R134a / 980g / US)
00817495024004 - GentleCool Pro Packaged 15-Pack of Cryogen (R134a / 980g / US)2024-05-31 Packaged 15-Pack of Cryogen (R134a / 980g / US)

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