Velscope Vx
510(k) K102083
Velscope Vx is a Class II device made by Led Dental, Inc., cleared under FDA 510(k) K102083 on 18 Nov 2010, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102083 | Date18 Nov 2010 | StatusActive |
Official records
- FDA 510(k) database K102083
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NXV
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6350
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K102083
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| VELscope VELcap Vx | 5710 / VELcap Vx | 07540201000025 | On the market | |
| VELscope VELsheath Vx | 5720 / VELsheath Vx | 07540201000032 | On the market | |
| VELscope Vx | 4200-1 / VELscope Vx | 07540201000018 | On the market | |
| VELscope Vx Value Bundle-Basic | 4660 / VELscope Vx Value Bundle-Basic | 07540201000094 | On the market | |
| VELscope Vx Value Bundle-US | 4662 / VELscope Vx Value Bundle-US | 07540201000049 | On the market |
Similar devices
Other devices filed under FDA product code NXV (Diagnostic Light, Soft Tissue Detector).
- G.o.c.c.l.e.s. by Pierrel Pharma S.R.L.
- 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.
- TRIMIRA OCS 3000 by Remicalm, LLC
- ORALID by Forward Science, LLC
- VIZILITE EYEWEAR by Zila, Inc.