VELSCOPE VX
Diagnostic Light, Soft Tissue Detector
LED DENTAL INC.
The following data is part of a premarket notification filed by Led Dental Inc. with the FDA for Velscope Vx.
Pre-market Notification Details
| Device ID | K102083 |
| 510k Number | K102083 |
| Device Name: | VELSCOPE VX |
| Classification | Diagnostic Light, Soft Tissue Detector |
| Applicant | LED DENTAL INC. 235-5589 BYRNE ROAD Burnaby , Bc, CA V5j 3j1 |
| Contact | David Morgan |
| Correspondent | David Morgan LED DENTAL INC. 235-5589 BYRNE ROAD Burnaby , Bc, CA V5j 3j1 |
| Product Code | NXV |
| CFR Regulation Number | 872.6350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-26 |
| Decision Date | 2010-11-18 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00754020100096 | K102083 | 000 |
| 00754020100041 | K102083 | 000 |
| 00754020100010 | K102083 | 000 |
| 07540201000094 | K102083 | 000 |
| 07540201000049 | K102083 | 000 |
| 27540201000036 | K102083 | 000 |
| 07540201000025 | K102083 | 000 |
| 07540201000018 | K102083 | 000 |
Trademark Results [VELSCOPE VX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VELSCOPE VX 85055257 4013550 Live/Registered |
LED Medical Diagnostics, Inc. 2010-06-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.