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510(k) K110228

NIDEK MULTICOLOR LASER PHOTOCOAGULATOR by Nidek Incorporated — Product Code HQB

K110228 is an FDA 510(k) premarket notification submitted by Nidek Incorporated for the device "NIDEK MULTICOLOR LASER PHOTOCOAGULATOR". The FDA issued a decision of Substantially Equivalent on February 23, 2011. The device falls under product code HQB (Photocoagulator And Accessories), a Class II device regulated under 21 CFR 886.4690.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2011
Date Received
January 26, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photocoagulator And Accessories
Device Class
Class II
Regulation Number
886.4690
Review Panel
OP
Submission Type

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FDA data resources