| Primary Device ID | 00817495022840 |
| NIH Device Record Key | 94e3282a-e747-4ff6-acc4-33322613523e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PicoWay 730nm Handpiece |
| Version Model Number | 7123-00-0497 |
| 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 | 00817495022840 [Primary] |
| GS1 | 08174950202844 [Previous] |
| 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 | 2019-11-18 |
| 08174950202844 | Handpiece Assembly |
| 00817495022840 | Handpiece Assembly |