| Primary Device ID | 00860009581784 |
| NIH Device Record Key | 1ba45f35-9a10-40db-8dcb-e1889f3dc571 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Luminance RED - Genital Sore PRO Device |
| Version Model Number | TN1927F |
| Company DUNS | 065554288 |
| Company Name | Luminance Medical Ventures Incorporated |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009581784 [Primary] |
| ILY | Lamp, Infrared, Therapeutic Heating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-14 |
| Device Publish Date | 2025-04-04 |
| 00860009581784 - The Luminance RED - Genital Sore PRO Device | 2025-04-14 |
| 00860009581784 - The Luminance RED - Genital Sore PRO Device | 2025-04-14 |
| 00860002593005 - Luminance RED Lip Device | 2023-06-05 |
| 00860002593043 - Luminance RED Mouth Device | 2023-06-05 |
| 00860002593050 - Luminance RED Genital Device | 2023-06-05 |
| 00860002593074 - Luminance RED Tip | 2023-06-05 |
| 00860002593036 - Luminance RED Acne Device | 2023-06-01 |