Primary Device ID | 00817495021812 |
NIH Device Record Key | 193f091e-3f5d-46e7-9a54-08b057d4ac59 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GentleLase Pro |
Version Model Number | 9914-11-9015 |
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 Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817495021812 [Primary] |
GS1 | 08174950201816 [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 | 6 |
Public Version Date | 2022-10-12 |
Device Publish Date | 2016-09-23 |
08174950202028 | Pulsed Laser |
08174950201823 | Pulsed Laser |
08174950201816 | Pulsed Laser |
08174950200888 | Pulsed Laser |
08174950200871 | Pulsed Laser |
08174950200376 | Pulsed Laser |
08174950200338 | Pulsed Laser |
08174950200079 | Pulsed Laser |
00817495020075 | Pulsed Laser |
00817495020372 | Pulsed Laser |
00817495020334 | Pulsed Laser |
00817495020884 | Pulsed Laser |
00817495020877 | Pulsed Laser |
00817495022024 | Pulsed Laser |
00817495021829 | Pulsed Laser |
00817495021812 | Pulsed Laser |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() GENTLELASE PRO 85239530 4092264 Live/Registered |
Candela Corporation 2011-02-10 |