Primary Device ID | 08174950200338 |
NIH Device Record Key | 6acef776-699b-4d48-abd0-9d7f79fa3254 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GentleLASE Pro |
Version Model Number | 9914-00-9315 |
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 |
Phone | 800-735-2737 |
customerservice@syneron-candela.com |
Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08174950200338 [Primary] |
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 | 4 |
Public Version Date | 2020-02-06 |
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 |