| Primary Device ID | 00817495024660 |
| NIH Device Record Key | 8443f040-e926-4209-947f-127c3b9adfc5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GMAX Pro Plus Laser System |
| Version Model Number | 9914-CH-9036 |
| Catalog Number | 9914-CH-9036 |
| 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 | 00817495024660 [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 | 2024-10-02 |
| Device Publish Date | 2024-09-24 |
| 00817495023540 - PicoWay Laser System | 2024-10-14 Picoway Laser System |
| 00817495023663 - PicoWay Laser System | 2024-10-14 Picoway Laser System |
| 00817495023588 - PicoWay Laser System | 2024-10-08 Picoway Laser System |
| 00817495024639 - GYAG Pro U Laser System | 2024-10-02 GYAG Pro U Laser System |
| 00817495024646 - Glase Pro U Laser System | 2024-10-02 Glase Pro U Laser System |
| 00817495024653 - GMAX Pro Laser System | 2024-10-02 GMAX Pro Laser System |
| 00817495024660 - GMAX Pro Plus Laser System | 2024-10-02GMAX Pro Plus Laser System |
| 00817495024660 - GMAX Pro Plus Laser System | 2024-10-02 GMAX Pro Plus Laser System |
| 00817495023977 - ASSY, ACC HAND PIECE, LARGE SPOT, GMPP | 2024-09-05 ASSY, ACC HAND PIECE, LARGE SPOT, GMPP |