Picoway
GUDID 00817495023113
Kit, PicoWay OXID Arm
CANDELA CORPORATION
Dermatological frequency-doubled solid-state laser system| Primary Device ID | 00817495023113 |
| NIH Device Record Key | cd49b9e8-c584-40d5-9529-131e442fa561 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Picoway |
| Version Model Number | 8901-00-9948 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817495023113 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-30 |
| Device Publish Date | 2022-05-20 |
On-Brand Devices [Picoway]
| 00817495021393 | Pulsed Laser |
| 00817495021010 | Pulsed Laser |
| 00817495020037 | Pulsed Laser |
| 00817495023113 | Kit, PicoWay OXID Arm |
Trademark Results [Picoway]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PICOWAY 87733320 not registered Live/Pending |
Chen Yuliang 2017-12-24 |
 PICOWAY 79138982 4531484 Live/Registered |
Candela Corporation 2013-09-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.