| Primary Device ID | 00817495023663 |
| NIH Device Record Key | 0d9e1a72-9a5a-43c9-b54d-f7c2af8e44f0 |
| Commercial Distribution Discontinuation | 2024-10-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PicoWay Laser System |
| Version Model Number | 9914-C1-9060 |
| 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 |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com | |
| Phone | 800-735-2737 |
| customerservice@syneron-candela.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817495023663 [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 | 2 |
| Public Version Date | 2024-10-14 |
| Device Publish Date | 2022-12-16 |
| 00817495023595 | Pulse Laser |
| 00817495023588 | Picoway Laser System |
| 00817495023663 | Picoway Laser System |
| 00817495023540 | Picoway Laser System |
| 00817495024677 | PicoWay Laser System |