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IntraLase FS Laser, IntraLase FS30 Laser, Models 1, 2, 3

by Intra Lase Corp.

510(k) K060372

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 NumberK060372 Date16 Aug 2006ClearedStatusActive

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  • Withdrawn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
Models / Variants
1
2
3
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The IntraLase FS and FS30 Laser is an ophthalmic surgical laser designed for lamellar corneal resections and incisions. The system utilizes tightly focused ultrashort laser pulses to perform microphotodisruption of corneal tissue.

This device is operated by physicians in clinical settings and includes a disposable applanation lens. During the procedure, the eye is fixated under low vacuum. The system is available in models 1, 2, and 3, and has received FDA 510k clearance.

Other devices from Intra Lase Corp.

See all devices from Intra Lase Corp. →

Questions

AI-generated answers, 6 Oct 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 IntraLase FS and FS30 Laser?

    The IntraLase FS and FS30 Laser is an ophthalmic surgical laser system used by physicians to perform lamellar corneal resections and incisions through microphotodisruption of corneal tissue.

  • What models are available for the IntraLase FS laser system?

    The system is available in three distinct versions, identified as models 1, 2, and 3. These models are designed to be operated by physicians in clinical settings using a disposable applanation lens and a low vacuum fixation method.

  • What is the regulatory status of the IntraLase FS laser?

    The IntraLase FS and FS30 Laser has received FDA 510k clearance, which indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.