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VELscope

FDA UDI

Class II (US FDA UDI)

by Led Dental, Inc.

Identity

Trade Name
VELscope FDA UDI
Generic Name
Medical equipment handle cover, single-use, non-sterile FDA UDI
Model / Reference
VELscope Vx Value Bundle-US FDA UDI

Identifiers

Catalog Number
4662 FDA UDI
Primary DI / UDI-DI
07540201000049 FDA UDI
510(k) Number
K102083 FDA UDI
FDA Product Code
NXV FDA UDI
GMDN Term
Medical equipment handle cover, single-use, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6350 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Optical medical device procedural coverMedical equipment handle cover, single-use, non-sterileOral lesion examination light

VELscope by Led Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral lesion examination light.

Cleared under the same submission

K102083 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Led Dental, Inc.

Sources (1)

  • FDA UDI 89e79e1e-0a79-4e07-9099-63ce266eb91b 34 fields · synced Jun 1, 2026