510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810817Substantially Equivalent

Exeter Operating Loupe

Exeter Instruments, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810817 is the FDA 510(k) clearance record for EXETER OPERATING LOUPE, a class I device, cleared for Exeter Instruments, Inc. on under FDA product code HOH (Spectacle, Operating (Loupe), Ophthalmic). FDA records list 2 510(k) clearances for Exeter Instruments, Inc., from to . As of , FDA records show no recalls naming K810817.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HOH Spectacle, Operating (Loupe), Ophthalmic
Regulation
21 CFR 886.4770
Device class
Class I
Review panel
Ophthalmic
Applicant
Exeter Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HOH

Trailing 12 months

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

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