Cleared Traditional

K080067 - ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER

K080067 is an FDA 510(k) clearance for ISCIENCE INTERVENTIONAL OPHTHALMIC MICR..., manufactured by Iscience Interventional. The device is a Class 2 Ophthalmic device with product code MPA cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K080067 · Iscience Interventional · Ophthalmic device
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Jul 2008
Decision
190d
Days
Class 2
Risk

K080067 is an FDA 510(k) clearance for the ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER. Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Iscience Interventional (Menlo Park, US). The FDA issued a Cleared decision on July 18, 2008 after a review of 190 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - 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 Iscience Interventional devices

FDA 510(k) Submission Details - K080067

510(k) Number K080067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2008
Decision Date July 18, 2008
Days to Decision 190 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
80d slower than avg
Panel avg: 110d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPA Device Classification - Class 2, Special Controls

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - MPA Endoilluminator

All 25
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