510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K854854Substantially Equivalent

Systems of Sight Low Vision Eyeware

Int'L Eye Care, Inc., Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854854 is the FDA 510(k) clearance record for SYSTEMS OF SIGHT LOW VISION EYEWARE, a class I device, cleared for Int'L Eye Care, Inc. on under FDA product code HOI (Spectacle, Magnifying). FDA records list one 510(k) clearance for Int'L Eye Care, Inc. As of , FDA records show no recalls naming K854854.

Clearance record

Decision date
Received
(61 days to decision)
Product code
HOI Spectacle, Magnifying
Regulation
21 CFR 886.5840
Device class
Class I
Review panel
Ophthalmic
Applicant
Int'L Eye Care, Inc. 67 Chestnut St., Suite 425, Rochester NY
Third party review
No

Clearances, product code HOI

Trailing 12 months

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

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