510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K072259Substantially Equivalent

Ophthalmoscope F-10

Nidek Co., Ltd., Marietta GA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072259 is the FDA 510(k) clearance record for OPHTHALMOSCOPE F-10, a class II device, cleared for Nidek Co., Ltd. on under FDA product code MYC (Ophthalmoscope, Laser, Scanning). FDA records list one 510(k) clearance for Nidek Co., Ltd. As of , FDA records show no recalls naming K072259.

Clearance record

Decision date
Received
(266 days to decision)
Product code
MYC Ophthalmoscope, Laser, Scanning
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
Nidek Co., Ltd. 1733 Canton Ln., Marietta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MYC

Trailing 12 months
1 clearance under product code MYC in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MYC, 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 20261
October 20260