| Primary Device ID | 00754016214028 |
| NIH Device Record Key | 2c56a3cc-bd40-4088-b1c0-1a3df44b8a90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bare 808 |
| Version Model Number | ESM-9300LD |
| Company DUNS | 204046564 |
| Company Name | Luvo Medical Technologies Inc |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00754016214028 [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 | 2021-06-10 |
| Device Publish Date | 2021-06-02 |
| 00754016214134 - Darwin | 2022-10-24 |
| 00754016214158 - Darwin IPL Handpiece | 2022-10-24 |
| 00754016214165 - Darwin Diode Laser Handpiece | 2022-10-24 |
| 00754016214172 - RF Microneedling Handpiece | 2022-10-24 |
| 00754016214189 - Darwin RF Thermal | 2022-10-24 |
| 00754016214127 - World PRP | 2021-08-19 |
| 00754016214028 - Bare 808 | 2021-06-10 |
| 00754016214028 - Bare 808 | 2021-06-10 |
| 00754016214035 - BARE: 808 HANDPIECE | 2021-06-10 |