Cleared Traditional

K090161 - EPIPHANY INJECTION SYSTEM

K090161 is an FDA 510(k) clearance for EPIPHANY INJECTION SYSTEM, manufactured by Staar Surgical Co.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K090161 · Staar Surgical Co. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
138d
Days
Class 1
Risk

K090161 is an FDA 510(k) clearance for the EPIPHANY INJECTION SYSTEM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on June 9, 2009 after a review of 138 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K090161

510(k) Number K090161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2009
Decision Date June 09, 2009
Days to Decision 138 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
28d slower than avg
Panel avg: 110d · This submission: 138d
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 K090161.
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
K091507 · Rayner Intraocular Lenses , Ltd. · Dec 2009
NAVIJECT SUB2-1P, MODEL: LP604430
K092023 · Medicel AG · Jul 2009
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
K082871 · Sis Ltd., Surgical Instrument Systems · Jul 2009
HOYA IS INJECTOR SYSTEM
K081346 · Hoya Surgical Optics, Inc. · Mar 2009
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · Bausch & Lomb, Inc. · Oct 2008
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
K081545 · Advanced Medical Optics, Inc. · Oct 2008
K090161 · EPIPHANY INJECTION SYSTEM
Download PDF FDA Summary Staar Surgical Co.