Cleared Traditional

K002556 - CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1

K002556 is an FDA 510(k) clearance for CEEON EASYSERT INTRAOCULAR LENS INJECTOR, manufactured by Pharmacia & Upjohn Co.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K002556 · Pharmacia & Upjohn Co. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
75d
Days
Class 1
Risk

K002556 is an FDA 510(k) clearance for the CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Pharmacia & Upjohn Co. (Pickerington,, US). The FDA issued a Cleared decision on October 31, 2000 after a review of 75 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 Pharmacia & Upjohn Co. devices

FDA 510(k) Submission Details - K002556

510(k) Number K002556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2000
Decision Date October 31, 2000
Days to Decision 75 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
35d faster than avg
Panel avg: 110d · This submission: 75d
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 24
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K002556.
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K073591 · Staar Surgical Co. · Mar 2008
MONARCH II IOL DELIVERY SYSTEM
K003768 · Alcon Research, Ltd. · Jan 2001
FOAM TIP INJECTOR
K980696 · Staar Surgical Co. · Sep 1998
MPORT FOLDABLE LENS PLACEMENT SYSTEM
K970727 · Chiron Vision Corp. · Dec 1997