Primary Device ID | 00817495020792 |
NIH Device Record Key | 9569a456-9eb2-40a5-a6ca-d05a7f01ae13 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GentleLASE |
Version Model Number | 9914-11-0930 |
Company DUNS | 053468385 |
Company Name | CANDELA CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817495020792 [Primary] |
GS1 | 08174950200796 [Previous] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-06-11 |
Device Publish Date | 2016-09-23 |
08174950202707 | Pulsed Laser |
08174950201809 | Pulsed Laser |
08174950200802 | Pulsed Laser |
08174950200796 | Pulsed Laser |
08174950200758 | Pulsed Laser |
08174950200741 | Pulsed Laser |
08174950200734 | Pulsed Laser |
08174950200727 | Pulsed Laser |
08174950200710 | Pulsed Laser |
08174950200703 | Pulsed Laser |
08174950200697 | Pulsed Laser |
08174950200680 | Pulsed Laser |
08174950200673 | Pulsed Laser |
08174950200246 | Pulsed Laser |
08174950200239 | Pulsed Laser |
08174950200222 | Pulsed Laser |
08174950200215 | Pulsed Laser |
08174950200093 | Pulsed Laser |
08174950200062 | Pulsed Laser |
00817495020242 | Pulsed Laser |
00817495020235 | Pulsed Laser |
00817495020228 | Pulsed Laser |
00817495020211 | Pulsed Laser |
00817495020099 | Pulsed Laser |
00817495020808 | Pulsed Laser |
00817495020792 | Pulsed Laser |
00817495020754 | Pulsed Laser |
00817495020747 | Pulsed Laser |
00817495020730 | Pulsed Laser |
00817495020723 | Pulsed Laser |
00817495020716 | Pulsed Laser |
00817495020709 | Pulsed Laser |
00817495020693 | Pulsed Laser |
00817495020686 | Pulsed Laser |
00817495020679 | Pulsed Laser |
00817495022703 | Pulsed Laser |
00817495021805 | Pulsed Laser |
00817495020068 | Pulsed Laser |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() GENTLELASE 75296996 2202250 Live/Registered |
Candela Corporation 1997-05-23 |