GentleYAG 9914-08-0950
GUDID 00817495022628
Pulsed Laser
CANDELA CORPORATION
Dermatological solid-state laser system| Primary Device ID | 00817495022628 |
| NIH Device Record Key | b585b868-8eba-4cb5-8b7f-c96f31824da1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GentleYAG |
| Version Model Number | 9914-08-0950 |
| Catalog Number | 9914-08-0950 |
| 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 |
Operating and Storage Conditions
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817495022628 [Primary] |
| GS1 | 08174950202622 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140122
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-06-23 |
| Device Publish Date | 2016-10-03 |
On-Brand Devices [GentleYAG]
| 08174950202639 | Pulsed Laser |
| 08174950202622 | Pulsed Laser |
| 08174950201892 | Pulsed Laser |
| 08174950201885 | Pulsed Laser |
| 08174950201878 | Pulsed Laser |
| 08174950201120 | Pulsed Laser |
| 08174950201113 | Pulsed Laser |
| 08174950201106 | Pulsed Laser |
| 08174950201090 | Pulsed Laser |
| 08174950201083 | Pulsed Laser |
| 08174950201076 | Pulsed Laser |
| 08174950201069 | Pulsed Laser |
| 08174950201052 | Pulsed Laser |
| 08174950200833 | Pulsed Laser |
| 08174950200826 | Pulsed Laser |
| 08174950200819 | Pulsed Laser |
| 08174950200321 | Pulsed Laser |
| 00817495020839 | Pulsed Laser |
| 00817495020822 | Pulsed Laser |
| 00817495020327 | Pulsed Laser |
| 00817495021126 | Pulsed Laser |
| 00817495021119 | Pulsed Laser |
| 00817495021102 | Pulsed Laser |
| 00817495021096 | Pulsed Laser |
| 00817495021089 | Pulsed Laser |
| 00817495021072 | Pulsed Laser |
| 00817495021065 | Pulsed Laser |
| 00817495021058 | Pulsed Laser |
| 00817495022635 | Pulsed Laser |
| 00817495022628 | Pulsed Laser |
| 00817495020815 | Pulsed Laser |
| 00817495021898 | Pulsed Laser |
| 00817495021881 | Pulsed Laser |
| 00817495021874 | Pulsed Laser |
Trademark Results [GentleYAG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENTLEYAG 76277865 2696488 Live/Registered |
Candela Corporation 2001-06-28 |
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