Primary Device ID | 00817495023465 |
NIH Device Record Key | 2b3d440f-9ac6-4c9f-8a07-b206c3389018 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Frax Pro |
Version Model Number | 9SYS7852-001-CNDL |
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 | 00817495023465 [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 | 2021-01-25 |
Device Publish Date | 2021-01-15 |
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 |
00817495024882 - Canister HFO-R1234 ZE / 950g, ALUM (US) | 2024-02-12 Canister HFO-R1234 ZE / 950g, ALUM (US) |
00817495024905 - Canister HFO-R1234 ZE / 950g, ALUM (Japan) | 2024-02-12 Canister HFO-R1234 ZE / 950g, ALUM (Japan) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FRAX PRO 90106842 not registered Live/Pending |
Candela Corporation 2020-08-11 |