| Primary Device ID | 00817495020556 |
| NIH Device Record Key | 69998977-8176-432d-9fae-5b491281a670 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alex TriVantage 532 Handpiece Kit Assembly |
| Version Model Number | 7122-00-9132 |
| 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 | 00817495020556 [Primary] |
| GS1 | 08174950200550 [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 | 4 |
| Public Version Date | 2020-06-11 |
| Device Publish Date | 2016-09-23 |
| 00817495020587 - Packaged 15-Pack of Cryogen (R134a / 980g / US) | 2024-05-06 Packaged 15-Pack of Cryogen (R134a / 980g / US) |
| 00817495023649 - Packaged 15-Pack of Cryogen (R134a / 980g / JP) | 2024-05-06 Packaged 15-Pack of Cryogen (R134a / 980g / JP) |
| 00817495024370 - Profound, SubQ Single- Use Cartridge, Packaged | 2024-03-08 Profound, SubQ Single- Use Cartridge, Packaged |
| 00817495024387 - Profound, Dermal Single- Use Cartridge, Packaged | 2024-03-08 Profound, Dermal Single- Use Cartridge, Packaged |
| 00817495023854 - GMPP Modified LSDS (HRDS) Options Kit for DCD | 2024-02-28 GMPP Modified LSDS (HRDS) Options Kit for DCD |
| 00817495023915 - GMPP Modified LSDS (HRDS) Options Kit for ACC | 2024-02-28 GMPP Modified LSDS (HRDS) Options Kit for ACC |
| 00817495025032 - HRDS Handpiece DCD Cooled | 2024-02-28 HRDS Handpiece DCD Cooled |
| 00817495025049 - HRDS Handpiece Air Cooled | 2024-02-28 HRDS Handpiece Air Cooled |