510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081346Substantially Equivalent

Hoya Is Injector System

Hoya Surgical Optics, Inc., Chino Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081346 is the FDA 510(k) clearance record for HOYA IS INJECTOR SYSTEM, a class I device, cleared for Hoya Surgical Optics, Inc. on under FDA product code MSS (Folders And Injectors, Intraocular Lens (Iol)). FDA records list one 510(k) clearance for Hoya Surgical Optics, Inc. As of , FDA records show no recalls naming K081346.

Clearance record

Decision date
Received
(313 days to decision)
Product code
MSS Folders And Injectors, Intraocular Lens (Iol)
Regulation
21 CFR 886.4300
Device class
Class I
Review panel
Ophthalmic
Applicant
Hoya Surgical Optics, Inc. 14768 Pipeline Ave., Chino Hills CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSS

Trailing 12 months
1 clearance under product code MSS in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MSS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260