Cleared Traditional

K062612 - RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04

K062612 is an FDA 510(k) clearance for RAYNER SINGLE USE SOFT TIPPED DISPOSABL..., 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 99-day FDA review.

K062612 · Rayner Surgical, Inc. · Ophthalmic device
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Dec 2006
Decision
99d
Days
Class 1
Risk

K062612 is an FDA 510(k) clearance for the RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04. 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 December 13, 2006 after a review of 99 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

FDA 510(k) Submission Details - K062612

510(k) Number K062612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2006
Decision Date December 13, 2006
Days to Decision 99 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
11d faster than avg
Panel avg: 110d · This submission: 99d
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 25
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K062612.
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MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
K073586 · Staar Surgical Co. · Mar 2008
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
K073591 · Staar Surgical Co. · Mar 2008
MONARCH II IOL DELIVERY SYSTEM
K003768 · Alcon Research, Ltd. · Jan 2001
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
K002556 · Pharmacia & Upjohn Co. · Oct 2000
FOAM TIP INJECTOR
K980696 · Staar Surgical Co. · Sep 1998