OrthoPulse
GUDID 00815950000013
Biolux Research Limited
Red-light phototherapy unit, line-powered| Primary Device ID | 00815950000013 |
| NIH Device Record Key | 98169b74-5750-43ea-8718-408093dfd3d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthoPulse |
| Version Model Number | OPi |
| Company DUNS | 243207607 |
| Company Name | Biolux Research Limited |
| 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
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com | |
| Phone | 8886690674 |
| support@orthopulse.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815950000013 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143120
FDA Product Code
| PLH | Orthodontic Led Accessory |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-23 |
Trademark Results [OrthoPulse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOPULSE 86448519 5078503 Live/Registered |
BIOLUX RESEARCH HOLDINGS, INC. 2014-11-07 |
 ORTHOPULSE 86173036 4960675 Live/Registered |
CuraMedix, LLC 2014-01-23 |
 ORTHOPULSE 79324604 not registered Live/Pending |
LLLT Technologies SA 2021-08-23 |
 ORTHOPULSE 76316740 2804038 Dead/Cancelled |
IMD-International Market Development BV 2001-09-25 |
 ORTHOPULSE 74198488 1753766 Dead/Cancelled |
IMD Innovative Medical Devices B.V. 1991-08-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.