ROYALE AE 9036 LSP INJECTOR— 510(k) K073010

Name: FDA 510(k) clearance K073010
Creator: U.S. Food and Drug Administration
Published: 2007-11-07

Substantially Equivalent

Asico, LLC

FDA 510(k) clearance K073010 for ROYALE AE 9036 LSP INJECTOR, Substantially Equivalent on 2007-11-07. Applicant: Asico, LLC. Device class: 1.

Clearance details

Applicant: Asico, LLC
Product code: Code MSS
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Date received: 2007-10-25
Decision date: 2007-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MSS

view all

K261174 — RxSight® Insertion Device2026-06-10
K252540 — ACCUJECT Injector Set 2.1-1P (LP604590)2025-09-16
K242389 — EyeGility Inserter for Preloaded enVista IOLs2024-10-10
K231106 — Accuject Refra Injector AR29002023-09-19
K231838 — RxSight® Insertion Device (63002)2023-08-15

More clearances from Asico, LLC

view all

K103495 — ASICO SOFTIP INJECTOR SYSTEM2011-06-29

Adverse events under product code MSS

product code MSS

Injury: 385
Malfunction: 2,033
Total: 2,418

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.