FDA 510(k) Applications for Medical Device Product Code "HQB"
(Photocoagulator And Accessories)

FDA 510(k) Number Applicant Device Name Decision Date
K110951 ALCON RESEARCH, LTD. 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA 10/17/2011
K111493 NIDEK CO., LTD. NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI 07/27/2011
K110228 NIDEK INCORPORATED NIDEK MULTICOLOR LASER PHOTOCOAGULATOR 02/23/2011
K964380 NK-OPTIK AMERICA LC-250 INFRARED LIGHT COAGULATOR 01/22/1997
K122997 PEREGRINE SURGICAL LTD. 23GA CURVED ILLUMINATING LASER PROBE 06/26/2013
K122905 PEREGRINE SURGICAL, LTD. PEREGRINE 23GA CURVED LASER PROBE 04/30/2013
K132614 PEREGRINE SURGICAL, LTD. PEREGRINE CURVED ILLUMINATING LASER PROBE 11/14/2013
K113857 SYNERGETICS, INC SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE 04/23/2012
K182646 Vitreq B.V. Vitreq disposable laser probes, light fibers and Chandelier 05/01/2019
K220263 Vortex Surgical Inc Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers 11/03/2022
K191846 Vortex Surgical Inc. MAXReach Laser Probe 12/23/2019


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