Cleared Traditional

C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02 (K052651) - FDA 510(k) Clearance

Class I Ophthalmic device.

K052651 · Rayner Surgical, Inc. · Ophthalmic device
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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.

View all Rayner Surgical, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 110d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 61
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