510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062895Substantially Equivalent

Xenon Brightstar Illumination System, Model 1266.Xiii

Dutch Ophthalmic Research Center International BV, Kingston NH / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062895 is the FDA 510(k) clearance record for XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII, a class II device, cleared for Dutch Ophthalmic Research Center International BV on under FDA product code MPA (Endoilluminator). FDA records list 4 510(k) clearances for Dutch Ophthalmic Research Center International BV, from to . As of , FDA records show no recalls naming K062895.

Clearance record

Decision date
Received
(16 days to decision)
Product code
MPA Endoilluminator
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Dutch Ophthalmic Research Center International BV One Little River Rd., Kingston NH
510(k) summary
Summary PDF
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