Alex
GUDID 00817495022017
Pulsed Laser
CANDELA CORPORATION
Dermatological frequency-doubled solid-state laser system| Primary Device ID | 00817495022017 |
| NIH Device Record Key | 11654df9-5327-4cd0-b63b-377778cc87fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alex |
| Version Model Number | 9914-00-2013 |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817495022017 [Primary] |
| GS1 | 08174950202011 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081324
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-08-24 |
| Device Publish Date | 2016-09-23 |
Devices Manufactured by CANDELA CORPORATION
| 00817495025070 - Refurbished Applicator Frax 1550 | 2025-05-28 Refurbished Applicator Frax 1550 |
| 00817495025087 - Refurbished Applicator Frax 1940 | 2025-05-28 Refurbished Applicator Frax 1940 |
| 00817495023960 - Nordlys Mini | 2025-03-18 Nordlys Mini Laser System |
| 00817495023526 - 1940 Applicator | 2025-03-14 1940 applicator (1940 nm) for Nordlys and Nordlys Mini |
| 00817495023953 - 1550 Applicator | 2025-03-14 1550 Applicator (1550 nm) for Nordlys and Nordlys Mini |
| 00817495024059 - Vbeam Prima Pro Laser System | 2025-01-23 Vbeam Prima Pro Laser System Nd: YAG Configuration 1064, 595, DCD |
| 00817495025247 - Vbeam Prima Pro DCD Handpiece | 2025-01-23 ASSY, DCD HP, DELIVERY SYSTEM, VBEAM PRIMA PRO |
| 00817495024677 - PicoWay Laser System | 2024-10-21 PicoWay Laser System |
Trademark Results [Alex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALEX 97774694 not registered Live/Pending |
Alex Renewable Energy Inc. 2023-01-31 |
 ALEX 97520531 not registered Live/Pending |
Out There First Inc. 2022-07-26 |
 ALEX 97080383 not registered Live/Pending |
Out There First Inc. 2021-10-18 |
 ALEX 88744944 not registered Live/Pending |
Sonny Cosmetics LLC 2020-01-02 |
 ALEX 88181028 not registered Live/Pending |
ALEX VALVE&CONTROL LTD 2018-11-05 |
 ALEX 88161699 5762997 Live/Registered |
Nasco Healthcare Inc. 2018-10-19 |
 ALEX 87883795 not registered Live/Pending |
The Jellyvision Lab, Inc. 2018-04-19 |
 ALEX 87705614 not registered Live/Pending |
Algebraix Data Corporation 2017-12-01 |
 ALEX 87705611 not registered Dead/Abandoned |
Algebraix Data Corporation 2017-12-01 |
 ALEX 87705609 not registered Live/Pending |
Algebraix Data Corporation 2017-12-01 |
 ALEX 87543574 5401544 Live/Registered |
Innovative Product Achievements, LLC 2017-07-26 |
 ALEX 87415003 5317126 Live/Registered |
Bio-Lab, Inc. 2017-04-18 |
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