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VELscope VELcap Vx

by Led Dental, Inc.

VELscope VELcap Vx (5710) 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 24 Sep 2016 (UDI-DI 07540201000025), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K102083

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07540201000025 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK102083 Date18 Nov 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K102083 decided 18 Nov 2010 Active
  • FDA GUDID UDI-DI 07540201000025 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K102083
  2. Listed FDA GUDID 07540201000025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VELscope
Generic name
Optical medical device procedural cover
Model / Ref / Catalog
VELcap Vx, 5710
Primary DI / UDI-DI
07540201000025
510(k) Number
FDA product code
NXV
GMDN term
Optical medical device procedural cover
Device class
Class II
Regulation number
872.6350
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)