GentleMax Pro
GUDID 00817495020013
Pulsed Laser
CANDELA CORPORATION
Dermatological solid-state laser system| Primary Device ID | 00817495020013 |
| NIH Device Record Key | 7621b06d-918f-41f6-a405-c7172641d82c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GentleMax Pro |
| Version Model Number | 9914-00-9035 |
| 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
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817495020013 [Primary] |
| GS1 | 08174950200017 [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 | 2020-05-13 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [GentleMax Pro ]
| 08174950200970 | Pulsed Laser |
| 08174950200963 | Pulsed Laser |
| 08174950200956 | Pulsed Laser |
| 08174950200277 | Pulsed Laser |
| 08174950200017 | Pulsed Laser |
| 00817495020013 | Pulsed Laser |
| 00817495020976 | Pulsed Laser |
| 00817495020969 | Pulsed Laser |
| 00817495020952 | Pulsed Laser |
| 00817495020273 | Pulsed Laser |
Trademark Results [GentleMax Pro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENTLEMAX PRO 85239469 4143836 Live/Registered |
Candela Corporation 2011-02-10 |
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