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ViziLite® 650199

by Den-Mat Holdings, LLC

ViziLite® 650199 is a Class I device made by Den-Mat Holdings, LLC, cleared under FDA 510(k) K033033 on 22 Nov 2004 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI D8136501991), active as of 22 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 22 Oct 2026

Documents

510(k) K033033

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD8136501991 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK033033 Date22 Nov 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K033033 decided 22 Nov 2004 Active
  • FDA GUDID UDI-DI D8136501991 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K033033
  2. Listed FDA GUDID D8136501991

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ViziLite®
Generic name
Oral lesion examination light
Model / Ref / Catalog
650199
Primary DI / UDI-DI
D8136501991
510(k) Number
FDA product code
EAZ
GMDN term
Oral lesion examination light
Device class
Class I
Regulation number
872.4630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Oral lesion examination light

Cleared under the same submission (K033033)

Similar devices

Other devices filed under FDA product code EAZ (Light, Operating, Dental).

Other devices from Den-Mat Holdings, LLC

See all devices from Den-Mat Holdings, LLC →

Properties

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