510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K073010Substantially Equivalent

Royale Ae 9036 Lsp Injector

Asico, LLC, Westmont IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073010 is the FDA 510(k) clearance record for ROYALE AE 9036 LSP INJECTOR, a class I device, cleared for Asico, LLC on under FDA product code MSS (Folders And Injectors, Intraocular Lens (Iol)). FDA records list 2 510(k) clearances for Asico, LLC, from to . As of , FDA records show no recalls naming K073010.

Clearance record

Decision date
Received
(13 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
Asico, LLC 26 Plz. Dr., Westmont IL
510(k) summary
Summary PDF
Third party review
Yes

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