510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133132Substantially Equivalent

Optical Biometer Al-Scan

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

K133132 is the FDA 510(k) clearance record for OPTICAL BIOMETER AL-SCAN, a class II device, cleared for Nidek Co., Ltd. on under FDA product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered). FDA records list 2 510(k) clearances for Nidek Co., Ltd., from to . As of , FDA records show one recall naming K133132.

Clearance record

Decision date
Received
(254 days to decision)
Product code
HJO Biomicroscope, Slit-Lamp, Ac-Powered
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Applicant
Nidek Co., Ltd. 755 N Mathilda Ave., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HJO

Trailing 12 months
2 clearances under product code HJO in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HJO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260