510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003299Unknown

Opd-Scan, Models Ark-10000 and Ark-9000

Nidek, Inc., Lake Forest CA / Traditional, Unknown
FDA source (opens on fda.gov)

K003299 is the FDA 510(k) clearance record for OPD-SCAN, MODELS ARK-10000 AND ARK-9000, a class I device, cleared for Nidek Co., Ltd. on under FDA product code HLQ (Keratoscope, Ac-Powered). FDA records list 10 510(k) clearances for Nidek Co., Ltd., from to . As of , FDA records show no recalls naming K003299.

Clearance record

Decision date
Received
(140 days to decision)
Product code
HLQ Keratoscope, Ac-Powered
Regulation
21 CFR 886.1350
Device class
Class I
Review panel
Ophthalmic
Applicant
Nidek Co., Ltd. 21911 Erie Ln., Lake Forest CA
510(k) summary
Summary
Third party review
No

Clearances, product code HLQ

Trailing 12 months

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

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