510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993883Substantially Equivalent

M-Pact Corneal Light Shield

M-Pact Corp., Eudora KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993883 is the FDA 510(k) clearance record for M-PACT CORNEAL LIGHT SHIELD, a class II device, cleared for M-Pact Corp. on under FDA product code HOZ (Sponge, Ophthalmic). FDA records list one 510(k) clearance for M-Pact Corp. As of , FDA records show no recalls naming K993883.

Clearance record

Decision date
Received
(36 days to decision)
Product code
HOZ Sponge, Ophthalmic
Regulation
21 CFR 886.4790
Device class
Class II
Review panel
Ophthalmic
Applicant
M-Pact Corp. 1040 0cl Pkwy.,, Eudora KS
510(k) summary
Summary
Third party review
No

Clearances, product code HOZ

Trailing 12 months

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

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