Product code HKN— Ophthalmic

COMPREHENSIVE PHOROPTER, MDR-680

Classification name: Refractor, Manual, Non-Powered, Including Phoropter
Device class: Class 1
Regulation: 21 CFR 886.1770
Advisory panel: Ophthalmic
Total cleared: 3
First cleared: 1979-01-26
Most recent: 1994-09-28

Market context for product code HKN

FDA has cleared 3 devices under product code HKN between 1979 and 1994, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19941 clearance
19871 clearance
19791 clearance

Top applicants under product code HKN

Woodlyn, Inc.1 clearance
Canon USA, Inc.1 clearance
American Optical Corp.1 clearance

Recent clearances under product code HKN

K936205 — COMPREHENSIVE PHOROPTER, MDR-680Canon USA, Inc.·1994-09-28
K874900 — WOODLYN CLASSIC REFRACTOR, PHOROPTORWoodlyn, Inc.·1987-12-23
K782118 — FUL-VUEAmerican Optical Corp.·1979-01-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.