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Optisource 74-0323-B

by Phoenix Healthcare Solutions, LLC

Optisource 74-0323-B is a Class II device made by Phoenix Healthcare Solutions, LLC, cleared under FDA 510(k) K231123 on 30 Aug 2023 and listed in FDA GUDID since 18 Aug 2024 (UDI-DI 00817096001411), 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) K231123

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 Number00817096001411 UDI-DI Date18 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK231123 Date30 Aug 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231123 decided 30 Aug 2023 Active
  • FDA GUDID UDI-DI 00817096001411 listed 18 Aug 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231123
  2. Listed FDA GUDID 00817096001411

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Optisource
Generic name
Contact lens case
Model / reference
74-0323-B
Primary DI / UDI-DI
00817096001411
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 (K231123)

and 8 more cleared under K231123

Similar devices

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

Other devices from Phoenix Healthcare Solutions, LLC

See all devices from Phoenix Healthcare Solutions, LLC →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)