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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