OrthoPulse OPi-NA100
GUDID 09120118090029
Biolux Technology GmbH
Red-light phototherapy unit, line-powered| Primary Device ID | 09120118090029 |
| NIH Device Record Key | 71ec7994-6514-489f-8167-319b08f92d74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthoPulse |
| Version Model Number | OPi |
| Catalog Number | OPi-NA100 |
| Company DUNS | 300613819 |
| Company Name | Biolux Technology GmbH |
| 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 | 00815950000013 [Previous] |
| GS1 | 09120118090029 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-08 |
| Device Publish Date | 2021-06-30 |
On-Brand Devices [OrthoPulse]
| 09120118090029 | OPi |
| 09120118090067 | OrthoPulse 2.0 Standard |
| 09120118090074 | OrthoPulse 2.0 Extended |
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 |
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