510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973229Substantially Equivalent

D.o.r.c. Hexon Illumination System

Dutch Ophthalmic USA, Inc., Kingston NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973229 is the FDA 510(k) clearance record for D.O.R.C. HEXON ILLUMINATION SYSTEM, a class II device, cleared for Dutch Ophthalmic USA, Inc. on under FDA product code MPA (Endoilluminator). FDA records list 10 510(k) clearances for Dutch Ophthalmic USA, Inc., from to . As of , FDA records show no recalls naming K973229.

Clearance record

Decision date
Received
(90 days to decision)
Product code
MPA Endoilluminator
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Dutch Ophthalmic USA, Inc. One Little River Rd., Kingston NH
510(k) summary
Summary
Third party review
No

Clearances, product code MPA

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