| Primary Device ID | 08809447654010 |
| NIH Device Record Key | 113cdeaf-2c7f-4934-93d0-81d5d19fefb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LaseMD Ultra |
| Version Model Number | Wire Remote Interlock Key |
| Company DUNS | 688282516 |
| Company Name | Lutronic Corporation |
| 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 | false |
| Manufacturing Date | false |
| 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 | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809447654010 [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 | 2020-07-27 |
| Device Publish Date | 2020-07-17 |
| 08809447653990 | Optic_Goggle (Doctor) |
| 08809447654010 | Wire Remote Interlock Key |
| 08809447653099 | ASSY_TIP_C5 |
| 08809447653082 | BLISTERED COMB SET_LaseMD Ultra |
| 08809447653075 | BLISTERED SQUARE SET_LaseMD Ultra |
| 08809447653068 | BLISTERED ROLLER SET_LaseMD Ultra |
| 08809447653044 | LaseMD Ultra U120V |
| 08809447653204 | LaseMD Ultra U120V case |
| 08809447653198 | cap_incubator |
| 08809447653181 | Patient goggle |
| 08809447653150 | AC POWER CABLE 3m |
| 08809447653143 | Foot Switch |
| 08809447653136 | LaseMD Ultra Operator's Manual for USA |
| 08809447653129 | Handpiece stand |
| 08809447653112 | Handpiece holder |
| 08809447653105 | HANDPIECE ASSY_LaseMD Ultra |