VELscope Vx
VELscope Vx (4200-1) is a Class II device made by Led Dental, Inc., cleared under FDA 510(k) K102083 on 18 Nov 2010 and listed in FDA GUDID since 22 Aug 2016 (UDI-DI 07540201000018), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07540201000018 | Date22 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102083 | Date18 Nov 2010 | StatusActive |
Official records
- AccessGUDID record 07540201000018
- FDA 510(k) database K102083
Across registries
- FDA 510(k) K102083 decided 18 Nov 2010 Active
- FDA GUDID UDI-DI 07540201000018 listed 22 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K102083
- Listed FDA GUDID 07540201000018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VELscope
- Generic name
- Oral lesion examination light
- Model / Ref / Catalog
- VELscope Vx, 4200-1
- Primary DI / UDI-DI
- 07540201000018
- 510(k) Number
- FDA product code
- NXV
- GMDN term
- Oral lesion examination light
- Device class
- Class II
- Regulation number
- 872.6350
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NXV (Diagnostic Light, Soft Tissue Detector).
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- VELSCOPE by Led Medical Diagnostics, Inc.
- BIO-SCREEN by Addent, Inc.
- Sapphire O/E Oral Examination System by Den-Mat Holdings, LLC
- DENTLIGHT ORAL EXAM LIGHT KIT by DENTLIGHT INC.
- TRIMIRA IDENTAFI 3000 by Remicalm, LLC
- MICROLUX/DL MICROLUX/BLU BIO/SCREEN by Addent, Inc.