510(k) K905453

CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND by Douglas James Donaldson Compliance Services — Product Code HQF

K905453 is an FDA 510(k) premarket notification submitted by Douglas James Donaldson Compliance Services for the device "CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND". The FDA issued a decision of Substantially Equivalent on March 5, 1991. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Douglas James Donaldson Compliance Services has at least 4 other 510(k) clearances on record.