| Primary Device ID | 00817495023595 |
| NIH Device Record Key | 0a3c6aaa-d898-401c-89b1-db8b2dd6a75a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PicoWay Laser System |
| Version Model Number | 9914-JB-9060 |
| 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 | 00817495023595 [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 | 2022-04-22 |
| Device Publish Date | 2022-04-14 |
| 00817495023595 | Pulse Laser |
| 00817495023588 | Picoway Laser System |
| 00817495023663 | Picoway Laser System |
| 00817495023540 | Picoway Laser System |
| 00817495024677 | PicoWay Laser System |