Cleared Traditional

K010852 - OSMED TISSUE EXPANDER

K010852 is an FDA 510(k) clearance for OSMED TISSUE EXPANDER, manufactured by Iop, Inc.. The device is a Class 2 Ophthalmic device with product code NFM cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K010852 · Iop, Inc. · Ophthalmic device
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Aug 2001
Decision
145d
Days
Class 2
Risk

K010852 is an FDA 510(k) clearance for the OSMED TISSUE EXPANDER. Classified as Expander, Tissue, Orbital (product code NFM), Class II - Special Controls.

Submitted by Iop, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on August 13, 2001 after a review of 145 days - within the typical 510(k) review window.

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 Iop, Inc. devices

FDA 510(k) Submission Details - K010852

510(k) Number K010852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2001
Decision Date August 13, 2001
Days to Decision 145 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 110d · This submission: 145d
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.