Cleared Traditional

K070669 - IOL INJECTOR SET (FDA 510(k) Clearance)

Class I Ophthalmic device.

K070669 · Medicel AG · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Nov 2007
Decision
234d
Days
Class 1
Risk

K070669 is an FDA 510(k) clearance for the IOL INJECTOR SET. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Medicel AG (Hasbrouck Heights, US). The FDA issued a Cleared decision on November 1, 2007 after a review of 234 days - an extended review 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: 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 Medicel AG devices

Submission Details

510(k) Number K070669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2007
Decision Date November 01, 2007
Days to Decision 234 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
124d slower than avg
Panel avg: 110d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYB Lens, Guide, Intraocular
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.