| Primary Device ID | 06977620360002 |
| NIH Device Record Key | 7a63a9e2-5f56-47e4-a1da-a03ffdeee072 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZHEONE |
| Version Model Number | FD-L01 |
| Company DUNS | 715544310 |
| Company Name | Hebei Zhemai 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 | true |
| 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 | 06977620360002 [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 | 2024-09-27 |
| Device Publish Date | 2024-09-19 |
| 06977620360026 | The Q-Switched Nd:Yag laser is indicated for the treatment of: benign cutaneous lesions, such as |
| 06977620360019 | The Intense pulsed light therapy device is indicated for use in surgical and aesthetic applicati |
| 06977620360002 | The Diode laser therapy device is intended for hair removal, permanent hair reduction on all ski |