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Cornisol

by Aurolab

510(k) K221759

Cornisol is a device classified as Unclassified made by Aurolab, cleared under FDA 510(k) K221759 on 5 Oct 2022, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221759 Date5 Oct 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LYX
Device class
U
Advisory committee
Unknown
FDA decision
SESE Substantially Equivalent

Devices cleared under K221759

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K221759
UDI-DISize and differences
Cornisol
AUROLAB
Cornisol00803878044226 —No longer on the market

Similar devices

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

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