Cleared Traditional

K081346 - HOYA IS INJECTOR SYSTEM

K081346 is an FDA 510(k) clearance for HOYA IS INJECTOR SYSTEM, manufactured by Hoya Surgical Optics, Inc.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K081346 · Hoya Surgical Optics, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
313d
Days
Class 1
Risk

K081346 is an FDA 510(k) clearance for the HOYA IS INJECTOR SYSTEM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Hoya Surgical Optics, Inc. (Chino Hills, US). The FDA issued a Cleared decision on March 23, 2009 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K081346

510(k) Number K081346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2008
Decision Date March 23, 2009
Days to Decision 313 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 110d · This submission: 313d
Pathway characteristics
Predicate-based equivalence.

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 62
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K081346.
NAVIJECT SUB2-1P, MODEL: LP604430
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XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
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EPIPHANY INJECTION SYSTEM
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CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · Bausch & Lomb, Inc. · Oct 2008
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
K081545 · Advanced Medical Optics, Inc. · Oct 2008
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
K081455 · Rayner Surgical, Inc. · Sep 2008
K081346 · HOYA IS INJECTOR SYSTEM
Download PDF FDA Summary Hoya Surgical Optics,…