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369
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700
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509
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483
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469
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412
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403
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391
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345
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343
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Manufacturers
US
Iridex Corp
Medical Device Manufacturer
·
US , Mountain View , CA
Iridex Corp - FDA 510(k) Cleared Devices
13 submissions
·
13 cleared
·
Since 1998
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Iridex Corp
Ophthalmic
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 14, 2006
IRIDEX WIRELESS FOOTSWITCH
K062074
·
HQF
Ophthalmic
·
116d
Cleared
Sep 20, 2004
IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
K040209
·
HQF
Ophthalmic
·
234d
Cleared
Aug 27, 2003
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS
K031665
·
HQF
Ophthalmic
·
90d
Cleared
May 03, 2002
OCULIGHT SL/SLX
K020374
·
HQF
Ophthalmic
·
88d
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13
General & Plastic Surgery
9
Ophthalmic
4