510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K936205Substantially Equivalent

Comprehensive Phoropter, Mdr-680

Canon Medical Components U.S.A., Inc., Lake Success NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K936205 is the FDA 510(k) clearance record for COMPREHENSIVE PHOROPTER, MDR-680, a class I device, cleared for Canon USA, Inc. on under FDA product code HKN (Refractor, Manual, Non-Powered, Including Phoropter). FDA records list 48 510(k) clearances for Canon Medical Components U.S.A., Inc., from to . As of , FDA records show no recalls naming K936205.

Clearance record

Decision date
Received
(273 days to decision)
Product code
HKN Refractor, Manual, Non-Powered, Including Phoropter
Regulation
21 CFR 886.1770
Device class
Class I
Review panel
Ophthalmic
Applicant
Canon USA, Inc. One Canon Plz., Lake Success NY
510(k) summary
Statement
Third party review
No

Clearances, product code HKN

Trailing 12 months

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

FDA records show no clearances under product code HKN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HKN, 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