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VELscope

FDA UDI

Class II (US FDA UDI)

by Led Dental, Inc.

Identity

Trade Name
VELscope FDA UDI
Generic Name
Oral lesion examination light FDA UDI
Model / Reference
VELscope Vx Value Bundle-Basic FDA UDI

Identifiers

Catalog Number
4660 FDA UDI
Primary DI / UDI-DI
07540201000094 FDA UDI
510(k) Number
K102083 FDA UDI
FDA Product Code
NXV FDA UDI
GMDN Term
Oral lesion examination light 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 ac0045e0-ef61-40ef-ba2f-32819740da25 34 fields · synced May 31, 2026