The following data is part of a premarket notification filed by Led Dental Inc. with the FDA for Velscope Vx.
| 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 | 
| 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 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  VELSCOPE VX  85055257  4013550 Live/Registered | LED Medical Diagnostics, Inc. 2010-06-04 |