| Primary Device ID | 08174950200413 |
| NIH Device Record Key | 15e6e321-b64d-417a-8a6b-09e869c34f9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GentleMax Limited Edition |
| Version Model Number | 9914-00-0330 |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08174950200413 [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 |
| 08174950200468 | Pulsed Laser |
| 08174950200420 | Pulsed Laser |
| 08174950200413 | Pulsed Laser |
| 08174950200406 | Pulsed Laser |
| 00817495020464 | Pulsed Laser |
| 00817495020426 | Pulsed Laser |
| 00817495020419 | Pulsed Laser |
| 00817495020402 | Pulsed Laser |