Cleared Traditional

K060151 - ORBITAL TISSUE EXPANDER (OTE)

K060151 is an FDA 510(k) clearance for ORBITAL TISSUE EXPANDER (OTE), manufactured by Innovia, LLC. The device is a Class 2 Ophthalmic device with product code NFM cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K060151 · Innovia, LLC · Ophthalmic device
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Aug 2006
Decision
200d
Days
Class 2
Risk

K060151 is an FDA 510(k) clearance for the ORBITAL TISSUE EXPANDER (OTE). Classified as Expander, Tissue, Orbital (product code NFM), Class II - Special Controls.

Submitted by Innovia, LLC (Miami, US). The FDA issued a Cleared decision on August 8, 2006 after a review of 200 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3320 - 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 Innovia, LLC devices

FDA 510(k) Submission Details - K060151

510(k) Number K060151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2006
Decision Date August 08, 2006
Days to Decision 200 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
90d slower than avg
Panel avg: 110d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFM Device Classification - Class 2, Special Controls

Product Code NFM Expander, Tissue, Orbital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3320
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.