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Optimum Classic roflufocon A

by Contamac Holdings Limited

Optimum Classic roflufocon A is a Class II device made by Contamac Holdings Limited, cleared under FDA 510(k) K033594 on 19 Mar 2004 and listed in FDA GUDID since 22 Jul 2020 (UDI-DI 00865576000232), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K033594

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 Number00865576000232 UDI-DI Date22 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK033594 Date19 Mar 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K033594 decided 19 Mar 2004 Active
  • FDA GUDID UDI-DI 00865576000232 listed 22 Jul 2020 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2982-2018 FDA Class III initiated 3 Jul 2018
    • Terminated Z-2981-2018 FDA Class III initiated 3 Jul 2018

    Vials labeled for the prescriptions contained incorrect lenses

Timeline

4 dated events

  1. Cleared FDA 510(k) K033594
  2. Recall initiated FDA recalls Z-2982-2018
  3. Recall initiated FDA recalls Z-2981-2018
  4. Listed FDA GUDID 00865576000232

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Optimum Classic
Generic name
Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
Model / Ref / Catalog
roflufocon A
Primary DI / UDI-DI
00865576000232
510(k) Number
FDA product code
HQD
GMDN term
Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
Device class
Class II
Regulation number
886.5916
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rigid-gas-permeable corrective contact lens, daily-wear

Cleared under the same submission (K033594)

Similar devices

Other devices filed under FDA product code HQD (Lens, Contact (Other Material) - Daily).

Other devices from Contamac Holdings Limited

See all devices from Contamac Holdings Limited →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)