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Cornisol

by Aurolab

Cornisol is a device classified as Unclassified made by Aurolab, cleared under FDA 510(k) K221759 on 5 Oct 2022 and listed in FDA GUDID since 27 Jun 2023 (UDI-DI 00803878044226), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K221759

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 Number00803878044226 UDI-DI Date27 Jun 2023ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK221759 Date5 Oct 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221759 decided 5 Oct 2022 Active
  • FDA GUDID UDI-DI 00803878044226 listed 27 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221759
  2. Listed FDA GUDID 00803878044226

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Corneal storage medium
Model / reference
Cornisol
Primary DI / UDI-DI
00803878044226
510(k) Number
FDA product code
LYX
GMDN term
Corneal storage medium
Device class
U
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code LYX (Media, Corneal Storage).

Other devices from Aurolab

See all devices from Aurolab →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)