510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843597Substantially Equivalent

Nidek Monocular Indirect Ophthalmoscope

Nidek, Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843597 is the FDA 510(k) clearance record for NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE, a class II device, cleared for Nidek, Inc. on under FDA product code HLI (Ophthalmoscope, Ac-Powered). FDA records list 32 510(k) clearances for Nidek, Inc., from to . As of , FDA records show no recalls naming K843597.

Clearance record

Decision date
Received
(156 days to decision)
Product code
HLI Ophthalmoscope, Ac-Powered
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
Nidek, Inc. P.O. Box 50488, Palo Alto CA
Third party review
No

Clearances, product code HLI

Trailing 12 months

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

FDA records show no clearances under product code HLI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HLI, 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