510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011498Substantially Equivalent

Easy Control Micro Inserter, Model On385

Ophtec USA, Inc., Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011498 is the FDA 510(k) clearance record for EASY CONTROL MICRO INSERTER, MODEL ON385, a class I device, cleared for Ophtec USA, Inc. on under FDA product code NCE (Injector, Capsular Tension Ring). FDA records list 2 510(k) clearances for Ophtec USA, Inc., from to . As of , FDA records show no recalls naming K011498.

Clearance record

Decision date
Received
(55 days to decision)
Product code
NCE Injector, Capsular Tension Ring
Regulation
21 CFR 886.4300
Device class
Class I
Review panel
Ophthalmic
Applicant
Ophtec USA, Inc. 6421 Congress Ave., Suite 112, Boca Raton FL
510(k) summary
Summary
Third party review
No

Clearances, product code NCE

Trailing 12 months

FDA records hold no clearances under product code NCE in the trailing twelve months.

FDA records show no clearances under product code NCE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NCE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260