| Primary Device ID | 08800023200881 |
| NIH Device Record Key | e9b1577c-a1f2-47ef-b110-a7259c1df5c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fraxis 1.1 Main Unit |
| Version Model Number | Fraxis 1.1 Main Unit |
| Company DUNS | 631129749 |
| Company Name | ILOODA.CO.,LTD |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800023200881 [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 | 2022-04-13 |
| Device Publish Date | 2022-04-05 |
| 08800023200942 - Secret DUO Main Unit | 2023-09-07 |
| 08800023200959 - Secret DUO Standard Handpiece | 2023-09-07 |
| 08800023201239 - Secret DUO Bigger Handpiece | 2023-09-07 |
| 08800023201390 - Secret DUO Laser Handpiece | 2023-09-07 |
| 08800023202168 - reepot Main Unit | 2023-09-07 |
| 08800023202175 - reepot Handpiece | 2023-09-07 |
| 08800023200218 - VIKINI Main Unit | 2023-06-19 |
| 08800023200225 - VIKINI Laser H/P | 2023-06-19 DET Laser H/P |