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Opti-Tears(R)

by Alcon Laboratories, Inc.

510(k) K890303

Opti-Tears(R) is a Class II device made by Alcon Laboratories, Inc., cleared under FDA 510(k) K890303 on 17 Feb 1989, 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 NumberK890303 Date17 Feb 1989ClearedStatusActive

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  • Withdrawn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
LPN
FDA applicant
Alcon Laboratories
Device class
Class II
Regulation
21 CFR Part 886.5928
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code LPN (Accessories, Soft Lens Products).

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