510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133358Substantially Equivalent

Nidek Multicolor Laser Photocoagulator System Mc-500 Connected with the Endophotocoagulation Delivery Unit

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

K133358 is the FDA 510(k) clearance record for NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT, a class II device, cleared for Nidek Co., Ltd. on under FDA product code HQF (Laser, Ophthalmic). FDA records list one 510(k) clearance for Nidek Co., Ltd. As of , FDA records show 2 recalls naming K133358.

Clearance record

Decision date
Received
(285 days to decision)
Product code
HQF Laser, Ophthalmic
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Nidek Co., Ltd. Via Dell'Artigianato, 6/A, Albignasego (Padova), IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HQF

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