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EZcase EZ11

by Watchdog Group, LC

EZcase EZ11 is a Class II device made by Watchdog Group, LC, cleared under FDA 510(k) K130753 on 13 Jun 2013 and listed in FDA GUDID since 6 Oct 2016 (UDI-DI 00897522001598), 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) K130753

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 Number00897522001598 UDI-DI Date6 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130753 Date13 Jun 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130753 decided 13 Jun 2013 Active
  • FDA GUDID UDI-DI 00897522001598 listed 6 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130753
  2. Listed FDA GUDID 00897522001598

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EZcase
Generic name
Contact lens case
Model / reference
EZ11
Primary DI / UDI-DI
00897522001598
510(k) Number
FDA product code
LRX
GMDN term
Contact lens case
Device class
Class II
Regulation number
886.5928
GUDID distribution status
In Commercial Distribution

Related devices

Category: Contact lens case

Cleared under the same submission (K130753)

and 1 more cleared under K130753

Similar devices

Other devices filed under FDA product code LRX (Case, Contact Lens).

Other devices from Watchdog Group, LC

  • Color Case CC17

    Class II

  • Color Case CC60

    Class II

  • Rexall DG11

    Class II

  • Color Case CC40

    Class II

See all devices from Watchdog Group, LC →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
Other properties (12, all answered No)