510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K903421Substantially Equivalent

Topcon Ec-200 Endo-Photocoagulator Laser

Top Con, Paramus NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903421 is the FDA 510(k) clearance record for TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER, a class II device, cleared for Top Con on under FDA product code HQF (Laser, Ophthalmic). FDA records list one 510(k) clearance for Top Con. As of , FDA records show no recalls naming K903421.

Clearance record

Decision date
Received
(140 days to decision)
Product code
HQF Laser, Ophthalmic
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Top Con 65 W. Century Rd., Paramus NJ
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