Cleared Traditional

OSMED TISSUE EXPANDER (K010852) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.