510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173980Substantially Equivalent

Specular Microscope CEM-530

Nidek Co., Ltd., Gamagori, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173980 is the FDA 510(k) clearance record for Specular Microscope CEM-530, a class II device, cleared for Nidek Co., Ltd. on under FDA product code NQE (Microscope, Specular). FDA's definition for product code NQE reads: "Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro". FDA records list 12 510(k) clearances for Nidek Co., Ltd., from to . As of , FDA records show one recall naming K173980.

Clearance record

Decision date
Received
(75 days to decision)
Product code
NQE Microscope, Specular
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Applicant
Nidek Co., Ltd. 34-14 Maehama, Hiroishi-Cho, Gamagori, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQE

Trailing 12 months

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

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