Cleared Special

K143307 - RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector (FDA 510(k) Clearance)

Class I Ophthalmic device.

K143307 · Rayner Intraocular Lenses , Ltd. · Ophthalmic device
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Dec 2014
Decision
30d
Days
Class 1
Risk

K143307 is an FDA 510(k) clearance for the RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Rayner Intraocular Lenses , Ltd. (Hove, GB). The FDA issued a Cleared decision on December 18, 2014 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Rayner Intraocular Lenses , Ltd. devices

Submission Details

510(k) Number K143307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2014
Decision Date December 18, 2014
Days to Decision 30 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 110d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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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