510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934459Substantially Equivalent

Med-Genesis Patient Laser Eye Shield

Med-Genesis, Inc., Great Neck, NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934459 is the FDA 510(k) clearance record for MED-GENESIS PATIENT LASER EYE SHIELD, a class I device, cleared for Med-Genesis, Inc. on under FDA product code IWS (Shield, Eye, Radiological). FDA records list one 510(k) clearance for Med-Genesis, Inc. As of , FDA records show no recalls naming K934459.

Clearance record

Decision date
Received
(165 days to decision)
Product code
IWS Shield, Eye, Radiological
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
Med-Genesis, Inc. 55 Northern Blvd., Suite 410, Great Neck, NY
510(k) summary
Statement
Third party review
No

Clearances, product code IWS

Trailing 12 months

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

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