Skip to content

Pulsion Fs Laser Keratome

by Intra Lase Corp.

510(k) K013941

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013941 Date27 Feb 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1124-03 FDA Unclassified (pre-2012) initiated 15 Jul 2003

    Gantry moves toward patient when 'Home' button is used after procedure.

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  • Withdrawn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

Other devices from Intra Lase Corp.

See all devices from Intra Lase Corp. →