| Primary Device ID | 06977863220606 |
| NIH Device Record Key | e931077a-69e2-43ab-a385-51ec1010aa5a |
| Commercial Distribution Discontinuation | 2025-04-09 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Therapy Light |
| Version Model Number | Kala Core |
| Company DUNS | 547460611 |
| Company Name | E.SHINE LIGHTING CO., LIMITED |
| 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 | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
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