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Catalys Precision Laser System

by Abbott Medical Optics, Inc.

510(k) K170322

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170322 Date19 May 2017ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0066-2019 FDA Class II initiated 9 May 2018

    Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI.

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  • Withdrawn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
OOE
Device Class
Class II
Regulation
21 CFR Part 886.4390
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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