Submission Details
| 510(k) Number | K102083 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 26, 2010 |
| Decision Date | November 18, 2010 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
VELSCOPE VX
Nov 2010
Decision
115d
Days
Class 2
Risk
About This 510(k) Submission
K102083 is an FDA 510(k) clearance for the VELSCOPE VX, a Diagnostic Light, Soft Tissue Detector (Class II — Special Controls, product code NXV), submitted by Led Dental, Inc. (Burnaby , Bc, CA). The FDA issued a Cleared decision on November 18, 2010, 115 days after receiving the submission on July 26, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.6350.
Device Classification
| Product Code | NXV — Diagnostic Light, Soft Tissue Detector |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.6350 |
| Definition | To Be Used As An Aid In The Detection Or Visualization Of Abnormalities Of Intraoral Soft Tissue. An Adjunct To Traditional Intraoral Examination By Incandescent Light To Enhance The Visualization Of Oral Mucosal Abnormalities |
Manufacturer
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