Cleared Traditional

K052651 - C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02

K052651 is an FDA 510(k) clearance for C-FLEX SYSTEM SINGLE USE DISPOSABLE INJ..., manufactured by Rayner Surgical, Inc.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K052651 · Rayner Surgical, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
115d
Days
Class 1
Risk

K052651 is an FDA 510(k) clearance for the C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Rayner Surgical, Inc. (Hove, East Sussex, GB). The FDA issued a Cleared decision on January 19, 2006 after a review of 115 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 - K052651

510(k) Number K052651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2005
Decision Date January 19, 2006
Days to Decision 115 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
5d slower than avg
Panel avg: 110d · This submission: 115d
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 K052651.
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
K060995 · Duckworth & Kent, Ltd. · May 2006
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM
K060533 · Lenstec, Inc. · Apr 2006
DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797
K053176 · Duckworth & Kent, Ltd. · Jan 2006
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
K050638 · Lenstec, Inc. · May 2005
MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
K040837 · Medicel AG · Jun 2004
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
K024072 · Duckworth & Kent, Ltd. · Oct 2003
K052651 · C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
Download PDF FDA Summary Rayner Surgical, Inc.