Koi Lacremal Hook & Dilator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812097 ↗

FDA Product Code

HNW

Device Class

Class I

Regulation

21 CFR Part 886.4350

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Koi Blue Field Entoptoscope

  Class II

  FDA 510(k) K812764 Active Cleared 2 Dec 1981

• Blade Gauge

  Class I

  FDA 510(k) K812011 Active Cleared 28 Jul 1981

• Koi Lacrimal Intubation System

  Class I

  FDA 510(k) K812010 Active Cleared 28 Jul 1981

• Koi Diamond Knife

  Class I

  FDA 510(k) K812450 Active Cleared 21 Sep 1981

• Diamond Knife

  Class I

  FDA 510(k) K830366 Active Cleared 9 Mar 1983

• Koi Pachymeter

  Class II

  FDA 510(k) K843247 Active Cleared 30 Apr 1986