| Primary Device ID | 06973071106084 |
| NIH Device Record Key | c314a2e5-f805-4c70-8ca3-4bf210570893 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hand-held IPL device (IPL Home Use Hair Removal Device) |
| Version Model Number | FZ-608 |
| Company DUNS | 707411576 |
| Company Name | Shenzhen IONKA Medical Technology 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06973071106084 [Primary] |
| OHT | Light Based Over-The-Counter Hair Removal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-09 |
| Device Publish Date | 2023-08-01 |
| 06973071106183 | IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is al |
| 06973071106084 | IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is al |
| 06973071102000 | IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is al |
| 06973071101003 | IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is al |