| Primary Device ID | 00860007876813 |
| NIH Device Record Key | c2401989-094b-4b20-8bd4-47a2f08437b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MD Elite LaserPro |
| Version Model Number | LaserPro |
| Company DUNS | 118440103 |
| Company Name | MDElite Laser and Aesthetic, LLC |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860007876813 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-07 |
| Device Publish Date | 2022-01-28 |
| 00860007876820 - iLightPro | 2022-07-18 iLightPro - Powered Laser Surgical Instrument - FDA 510(k) K190938 |
| 00860007876837 - iProElite | 2022-07-18 iProElite - Diode Laser System - FDA 510(k) K212478 |
| 00860007876813 - MD Elite LaserPro | 2022-02-07MD Elite LaserPro - Diode Laser System - FDA 510(k) K212478 |
| 00860007876813 - MD Elite LaserPro | 2022-02-07 MD Elite LaserPro - Diode Laser System - FDA 510(k) K212478 |
| 00860007876806 - MDElite iProX | 2022-02-02 MDElite iProX - Intense Pulsed Light Equipment - AC110V 50/60Hz 2500VA 34*57*118cm 62kg - FDA 510(k) K193328 |