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Lightsheer Pulsed Diode Array Laser System

by Coherent Star

510(k) K003614

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK003614 Date13 Mar 2001ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1519-2015 FDA Class II initiated 25 Mar 2015

    Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type resulting in insufficient treatment effect. May result in patient burns and hypopigmentation.

    • Terminated Z-0556-06 FDA Unclassified (pre-2012) initiated 9 Feb 2006

    During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.

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  • Withdrawn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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