| Primary Device ID | 00816722022431 |
| NIH Device Record Key | 3ec5c804-32d5-4893-8009-9312122337ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | truSculpt 3D |
| Version Model Number | truSculpt 3D |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816722022431 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-06-26 |
| Device Publish Date | 2017-03-27 |
| 00816722022806 - Acutip | 2023-05-23 Acutip IPL Handpiece for xeo+/xeo+ SA |
| 00816722021809 - xeo+ | 2022-12-08 xeo+ Laser System |
| 00816722021816 - xeo+ SA | 2022-12-08 xeo+ SA IPL System |
| 00816722022813 - Limelight | 2022-12-08 Limelight IPL Handpiece for xeo+/xeo+ SA |
| 00816722022820 - Prowave | 2022-12-08 Prowave IPL Handpiece for xeo+/xeo+ SA |
| 00816722022837 - Titan | 2022-12-08 Titan IPL Handpiece for xeo+/xeo+ SA |
| 00816722022844 - Pearl Fractional | 2022-12-08 Pearl Fractional Laser Handpiece for xeo+/xeo+ SA |
| 00816722022479 - truSculpt 2 RF handpiece | 2022-11-22 truSculpt 2 cm^2 handheld handpiece for use with truSculpt iD RF device |