The following data is part of a premarket notification filed by Led Dental Inc. with the FDA for Modification To: Velscope.
| Device ID | K070523 |
| 510k Number | K070523 |
| Device Name: | MODIFICATION TO: VELSCOPE |
| Classification | Diagnostic Light, Soft Tissue Detector |
| Applicant | LED DENTAL INC. #201-15047 MARINE DR. White Rock, British Columbia, CA V4b 1c5 |
| Contact | David C Morgan, Phd |
| Correspondent | David C Morgan, Phd LED DENTAL 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 | 2007-02-23 |
| Decision Date | 2007-04-05 |
| Summary: | summary |