GentleMax
GUDID 00817495020198
Pulsed Laser
CANDELA CORPORATION
Dermatological solid-state laser system| Primary Device ID | 00817495020198 |
| NIH Device Record Key | 5d5c2e39-0d31-4e09-9577-12eabf3332de |
| Commercial Distribution Discontinuation | 2020-06-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | GentleMax |
| Version Model Number | 9914-00-0420 |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817495020198 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140732
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 | 6 |
| Public Version Date | 2020-07-01 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [GentleMax]
| 08174950201045 | Pulsed Laser |
| 08174950201038 | Pulsed Laser |
| 08174950200642 | Pulsed Laser |
| 08174950200635 | Pulsed Laser |
| 08174950200574 | Pulsed Laser |
| 08174950200505 | Pulsed Laser |
| 08174950200482 | Pulsed Laser |
| 08174950200475 | Pulsed Laser |
| 08174950200192 | Pulsed Laser |
| 08174950200185 | Pulsed Laser |
| 00817495020198 | Pulsed Laser |
| 00817495020181 | Pulsed Laser |
| 00817495020648 | Pulsed Laser |
| 00817495020631 | Pulsed Laser |
| 00817495020570 | Pulsed Laser |
| 00817495020501 | Pulsed Laser |
| 00817495020488 | Pulsed Laser |
| 00817495020471 | Pulsed Laser |
| 00817495021034 | Pulsed Laser |
| 00817495021041 | Pulsed Laser |
Trademark Results [GentleMax]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENTLEMAX 77065524 3517090 Dead/Cancelled |
Candela Corporation 2006-12-15 |
 GENTLEMAX 77043385 3517024 Dead/Cancelled |
Candela Corporation 2006-11-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.