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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Underwriters Laboratories, Inc.
SILVIA ANKOVA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 62
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K073010.
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
K081455 · Rayner Surgical, Inc. · Sep 2008
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
K073586 · Staar Surgical Co. · Mar 2008
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
K073591 · Staar Surgical Co. · Mar 2008
LENSTEC LC INJECTION SYSTEM
K063802 · Lenstec, Inc. · May 2007
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04
K062612 · Rayner Surgical, Inc. · Dec 2006
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
K060995 · Duckworth & Kent, Ltd. · May 2006
K073010 · ROYALE AE 9036 LSP INJECTOR
Download PDF FDA Summary Asico, LLC