ClearanceBrief
Recall Z-0228-04 ยท HQF Laser, Ophthalmic

LightMed USA Inc

Model LightLas 532 Opthalmic Photocoagulator Laser

DateDec 17, 2003 (initiated Nov 11, 2003)
StatusTerminated
ReasonFirm needed to include calibration procedures in user guide.
Root causeOther
ActionFirm fedexed new user manuals with calibration procedures to each consignee on 11/11/2003.
Quantity2
DistributionCA, GA
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K010372LIGHTLAS 532 PHOTOCOAGULATOR
Lightmed Corp., Aug 22, 2001
K990075LPULSA SYL-9000 OPHTHALMIC YAG LASER
Light-Med(Usa), Inc., Mar 30, 1999