| Primary Device ID | 00816722022356 |
| NIH Device Record Key | 6252efa6-9910-42e0-966d-3ba35f1b79c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Genesis V |
| Version Model Number | Genesis V |
| Company DUNS | 041071643 |
| Company Name | CUTERA, INC. |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 1 415 657-5500 |
| info@cutera.com | |
| Phone | 1 415 657-5500 |
| info@cutera.com | |
| Phone | 1 415 657-5500 |
| info@cutera.com | |
| Phone | 1 415 657-5500 |
| info@cutera.com | |
| Phone | 1 415 657-5500 |
| info@cutera.com | |
| Phone | 1 415 657-5500 |
| info@cutera.com | |
| Phone | 1 415 657-5500 |
| info@cutera.com | |
| Phone | 1 415 657-5500 |
| info@cutera.com | |
| Phone | 1 415 657-5500 |
| info@cutera.com | |
| Phone | 1 415 657-5500 |
| info@cutera.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816722022356 [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 | 2019-07-23 |
| Device Publish Date | 2019-07-15 |
| 00816722022318 | Genesis V Laser Handpiece |
| 00816722022356 | Genesis V Laser Handpiece for EV+ |