| Primary Device ID | 00817495024448 |
| NIH Device Record Key | 3b62964a-f1ff-4bc8-9c66-63e37bc34491 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intima hygienic Accessories Kit, CO2RE |
| Version Model Number | KT77003 |
| Catalog Number | KT77003 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817495024448 [Primary] |
| GS1 | 07290109952673 [Previous] |
| 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 | 2023-10-30 |
| Device Publish Date | 2023-10-20 |
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| 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 | 2024-10-02 GMAX Pro Plus Laser System |