510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922378Substantially Equivalent

Ophthalmic Knife

Microptics Development Laboratory, Newport Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922378 is the FDA 510(k) clearance record for OPHTHALMIC KNIFE, a class I device, cleared for Microptics Development Laboratory on under FDA product code HNN (Knife, Ophthalmic). FDA records list one 510(k) clearance for Microptics Development Laboratory. As of , FDA records show no recalls naming K922378.

Clearance record

Decision date
Received
(204 days to decision)
Product code
HNN Knife, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Microptics Development Laboratory 3855 Birch St., Newport Beach CA
510(k) summary
Summary
Third party review
No

Clearances, product code HNN

Trailing 12 months

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

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