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VELscope

FDA UDI

Class II (US FDA UDI)

by Led Dental, Inc.

Identity

Trade Name
VELscope FDA UDI
Generic Name
Optical medical device procedural cover FDA UDI
Model / Reference
VELcap Vx FDA UDI

Identifiers

Catalog Number
5710 FDA UDI
Primary DI / UDI-DI
07540201000025 FDA UDI
510(k) Number
K102083 FDA UDI
FDA Product Code
NXV FDA UDI
GMDN Term
Optical medical device procedural cover 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Optical medical device procedural cover

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

Similar devices

Also classified as Optical medical device procedural cover.

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 18139c60-66ae-4fc8-a03d-c4f5365ac249 34 fields · synced May 31, 2026