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Manufacturers
US
Dioptics
Medical Device Manufacturer
·
US , Irvine , CA
Dioptics - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1986
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dioptics
Ophthalmic
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 05, 1990
SOLARSHIELDS ENCORE
K903487
·
HQY
Ophthalmic
·
97d
Cleared
Feb 22, 1989
SOLARETTES
K884878
·
HQY
Ophthalmic
·
93d
Cleared
Dec 30, 1988
DIOPTICS EYESHIELDS
K885163
·
HOY
Ophthalmic
·
17d
Cleared
Aug 21, 1986
SOLARSHIELDS
K862719
·
HQY
Ophthalmic
·
35d
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6
Ophthalmic
4
General Hospital
2