Cleared Traditional

K073010 - ROYALE AE 9036 LSP INJECTOR

K073010 is an FDA 510(k) clearance for ROYALE AE 9036 LSP INJECTOR, manufactured by Asico, LLC. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K073010 · Asico, LLC · Ophthalmic device
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Nov 2007
Decision
13d
Days
Class 1
Risk

K073010 is an FDA 510(k) clearance for the ROYALE AE 9036 LSP INJECTOR. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Asico, LLC (Westmont, US). The FDA issued a Cleared decision on November 7, 2007 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Asico, LLC devices

FDA 510(k) Submission Details - K073010

510(k) Number K073010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2007
Decision Date November 07, 2007
Days to Decision 13 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 110d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

MSS Device Classification - Class 1, General Controls

Product Code MSS Folders And Injectors, Intraocular Lens (iol)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSS Folders And Injectors, Intraocular Lens (iol)

All 25
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K073010.
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K073591 · Staar Surgical Co. · Mar 2008
MONARCH II IOL DELIVERY SYSTEM
K003768 · Alcon Research, Ltd. · Jan 2001
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
K002556 · Pharmacia & Upjohn Co. · Oct 2000
FOAM TIP INJECTOR
K980696 · Staar Surgical Co. · Sep 1998