Primary Device ID | 03830054230897 |
NIH Device Record Key | 40d2701e-e134-4bdc-a77c-b97917139a3e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lightwalker ST-E ADVANCED |
Version Model Number | M002-6A/2 ADVANCED |
Company DUNS | 644720625 |
Company Name | FOTONA d.o.o. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
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 | false |
OTC Over-The-Counter | false |
Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03830054230897 [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 | 4 |
Public Version Date | 2020-02-06 |
Device Publish Date | 2016-09-19 |
03830054230897 | The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invi |
03830054230347 | The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invi |