510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050336Substantially Equivalent

Opd-Station Software

Nidek, Inc., Lake Forest CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050336 is the FDA 510(k) clearance record for OPD-STATION SOFTWARE, a class I device, cleared for Nidek, Inc. on under FDA product code NCF (Aberrometer, Ophthalmic). FDA records list 10 510(k) clearances for Nidek, Inc., from to . As of , FDA records show no recalls naming K050336.

Clearance record

Decision date
Received
(195 days to decision)
Product code
NCF Aberrometer, Ophthalmic
Regulation
21 CFR 886.1760
Device class
Class I
Review panel
Ophthalmic
Applicant
Nidek, Inc. 21911 Erie Ln., Lake Forest CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NCF

Trailing 12 months

FDA records hold no clearances under product code NCF in the trailing twelve months.

FDA records show no clearances under product code NCF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NCF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260