| Primary Device ID | 05700002165428 |
| NIH Device Record Key | 58aea29d-cb65-461f-8942-a91ff0ec1f09 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Norlase LION photocoagulator |
| Version Model Number | N006-9200 |
| Company DUNS | 305483903 |
| Company Name | Norlase ApS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | true |
| 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 | 05700002165428 [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 | 2020-09-08 |
| Device Publish Date | 2020-08-31 |
| 05700002165466 - Norlase LYNX photocoagulator | 2024-11-07 The Norlase LYNX photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagul |
| 05700002165442 - Norlase LEAF photocoagulator | 2023-12-14 The Norlase LEAF Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagul |
| 05700002165459 - Norlase ECHO photocoagulator | 2023-12-14 The Norlase ECHO Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagul |
| 05700002165435 - Norlase ECHO photocoagulator | 2022-11-23 The Norlase ECHO Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagul |
| 05700002165428 - Norlase LION photocoagulator | 2020-09-08The Norlase LION Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty |
| 05700002165428 - Norlase LION photocoagulator | 2020-09-08 The Norlase LION Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagul |
| 05700002165411 - Norlase Leaf photocoagulator | 2019-10-21 The Norlase Leaf Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagul |