Cleared Traditional

K070669 - IOL INJECTOR SET

K070669 is an FDA 510(k) clearance for IOL INJECTOR SET, manufactured by Medicel AG. The device is a Class 1 Ophthalmic device with product code KYB cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K070669 · Medicel AG · Ophthalmic device
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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

FDA 510(k) Submission Details - K070669

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 110d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

KYB Device Classification - Class 1, General Controls

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.

Regulatory Peers - KYB Lens, Guide, Intraocular

All 24
Devices cleared under the same product code (KYB) and FDA review panel - the closest regulatory comparables to K070669.
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