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IFS Laser System

by Abbott Medical Optics, Inc.

510(k) K113151

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113151 Date8 Mar 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IFS Laser System is an ophthalmic surgical laser designed for use in the creation of a corneal flap. It is indicated for patients undergoing LASIK surgery or other treatments that require initial lamellar resection of the cornea.

This device is authorized under FDA 510(k) clearance K113151. It is manufactured by Abbott Medical Optics, Inc. and is intended for clinical use in ophthalmic surgical procedures.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical use of the IFS Laser System?

    The IFS Laser System is designed for ophthalmic surgical procedures. It is specifically indicated for the creation of a corneal flap in patients undergoing LASIK surgery or other treatments that require initial lamellar resection of the cornea.

  • What is the regulatory status of this laser system?

    The IFS Laser System is authorized under FDA 510(k) clearance, identified by the k-number K113151. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.

  • Who is the manufacturer of the IFS Laser System?

    The device is manufactured by Abbott Medical Optics, Inc., located in Santa Ana, California. They are the applicant responsible for the 510(k) submission and regulatory documentation for this system.