The following data is part of a premarket notification filed by Led Medical Diagnostics Inc. with the FDA for Velscope.
| Device ID | K060920 | 
| 510k Number | K060920 | 
| Device Name: | VELSCOPE | 
| Classification | Diagnostic Light, Soft Tissue Detector | 
| Applicant | LED MEDICAL DIAGNOSTICS INC. #201-15047 MARINE DR. White Rock, British Columbia, CA V4b 1c5 | 
| Contact | David C Morgan | 
| Correspondent | David C Morgan LED MEDICAL DIAGNOSTICS INC. #201-15047 MARINE DR. White Rock, British Columbia, CA V4b 1c5 | 
| Product Code | NXV | 
| CFR Regulation Number | 872.6350 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2006-04-04 | 
| Decision Date | 2006-04-27 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  VELSCOPE  78510940  3169666 Live/Registered | LED Medical Diagnostics, Inc. 2004-11-03 |