510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802351Substantially Equivalent

F110 Photo Binocular Ophthalmoscope

Minami, Tomine & Lew, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802351 is the FDA 510(k) clearance record for F110 PHOTO BINOCULAR OPHTHALMOSCOPE, a class I device, cleared for Minami, Tomine & Lew on under FDA product code HLG (Pupillometer, Ac-Powered). FDA records list one 510(k) clearance for Minami, Tomine & Lew. As of , FDA records show no recalls naming K802351.

Clearance record

Decision date
Received
(83 days to decision)
Product code
HLG Pupillometer, Ac-Powered
Regulation
21 CFR 886.1700
Device class
Class I
Review panel
Ophthalmic
Applicant
Minami, Tomine & Lew 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HLG

Trailing 12 months

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

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