510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910124Substantially Equivalent

Low Vision Enhancement System (Lves)

Triangle Investments, Baltimore MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910124 is the FDA 510(k) clearance record for LOW VISION ENHANCEMENT SYSTEM (LVES), a class I device, cleared for Triangle Investments on under FDA product code HPG (Aid, Vision, Electronic, Battery-Powered). FDA records list one 510(k) clearance for Triangle Investments. As of , FDA records show no recalls naming K910124.

Clearance record

Decision date
Received
(89 days to decision)
Product code
HPG Aid, Vision, Electronic, Battery-Powered
Regulation
21 CFR 886.5900
Device class
Class I
Review panel
Ophthalmic
Applicant
Triangle Investments 1629 Thames St., Baltimore MD
Third party review
No

Clearances, product code HPG

Trailing 12 months

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

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