| Primary Device ID | 08033945934927 |
| NIH Device Record Key | df10ec33-8041-413a-8eb7-aa49ff4698fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | na |
| Version Model Number | OAM001193 |
| Company DUNS | 436045833 |
| Company Name | QUANTA SYSTEM SPA |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033945934927 [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 | 2021-05-24 |
| Device Publish Date | 2016-08-29 |
| 08033945935894 | Intense Pulsed Light handpiece 625 nm 48x13 |
| 08033945934996 | Removable Waveguide 650-1200 nm 48x13 |
| 08033945934989 | Removable Waveguide 400-1200nm 25x13 |
| 08033945934972 | Removable Waveguide 550-1200 nm 25x13 |
| 08033945934965 | Removable Waveguide 570-1200 nm 25 x13 |
| 08033945934958 | Removable Waveguide 590-1200 nm 25 x13 |
| 08033945934941 | Removable Waveguide 625-1200 nm 25 x13 |
| 08033945934934 | Removable Waveguide 400-1200 nm 48 x13 |
| 08033945934927 | Removable Waveguide 550-1200 nm 48 x13 |
| 08033945934910 | Removable Waveguide 570-1200 nm 48 x13 |
| 08033945934903 | Removable Waveguide 590-1200 nm 48 x13 |
| 08033945934897 | Removable Waveguide 625-1200 nm 48 x13 |