510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915340Substantially Equivalent

Mentor Horizon Low Vision Magnifier

Mentor O & O, Inc., Norwell MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915340 is the FDA 510(k) clearance record for MENTOR HORIZON LOW VISION MAGNIFIER, a class I device, cleared for Mentor O & O, Inc. on under FDA product code HJG (System, Reading, Television, Closed-Circuit). FDA records list 18 510(k) clearances for Mentor O & O, Inc., from to . As of , FDA records show no recalls naming K915340.

Clearance record

Decision date
Received
(158 days to decision)
Product code
HJG System, Reading, Television, Closed-Circuit
Regulation
21 CFR 886.5820
Device class
Class I
Review panel
Ophthalmic
Applicant
Mentor O & O, Inc. 3000 Longwater Dr., Norwell MA
510(k) summary
Statement
Third party review
No

Clearances, product code HJG

Trailing 12 months

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

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