| Primary Device ID | 00817495023458 |
| NIH Device Record Key | 353904ad-19bb-478a-b5f9-cbf894935a54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nordlys System |
| Version Model Number | 9SYS7751-203 |
| Company DUNS | 053468385 |
| Company Name | CANDELA 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 | 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 | 00817495023458 [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 | 2022-05-30 |
| Device Publish Date | 2022-05-20 |
| 00817495024370 - Profound, SubQ Single- Use Cartridge, Packaged | 2024-03-08 Profound, SubQ Single- Use Cartridge, Packaged |
| 00817495024387 - Profound, Dermal Single- Use Cartridge, Packaged | 2024-03-08 Profound, Dermal Single- Use Cartridge, Packaged |
| 00817495023854 - GMPP Modified LSDS (HRDS) Options Kit for DCD | 2024-02-28 GMPP Modified LSDS (HRDS) Options Kit for DCD |
| 00817495023915 - GMPP Modified LSDS (HRDS) Options Kit for ACC | 2024-02-28 GMPP Modified LSDS (HRDS) Options Kit for ACC |
| 00817495025032 - HRDS Handpiece DCD Cooled | 2024-02-28 HRDS Handpiece DCD Cooled |
| 00817495025049 - HRDS Handpiece Air Cooled | 2024-02-28 HRDS Handpiece Air Cooled |
| 00817495024882 - Canister HFO-R1234 ZE / 950g, ALUM (US) | 2024-02-12 Canister HFO-R1234 ZE / 950g, ALUM (US) |
| 00817495024905 - Canister HFO-R1234 ZE / 950g, ALUM (Japan) | 2024-02-12 Canister HFO-R1234 ZE / 950g, ALUM (Japan) |