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Intralase Fs Laser

by Intra Lase Corp. 2 variants

510(k) K031960

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK031960 Date29 Sep 2003ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0167-2012 FDA Unclassified (pre-2012) initiated 12 Oct 2011 on shared 510(k) K031960
    • Terminated Z-0166-2012 FDA Unclassified (pre-2012) initiated 12 Oct 2011 on shared 510(k) K031960
    • Terminated Z-0165-2012 FDA Unclassified (pre-2012) initiated 12 Oct 2011 on shared 510(k) K031960

    The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or deeper) created using the Laser System.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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

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