Cleared Traditional

K871473 - PART #860065 IA PAK & PART #860060 IA PAK

K871473 is the FDA 510(k) clearance for PART #860065 IA PAK & PART #860060 IA PAK by Medical Technical Products. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K871473 · Medical Technical Products · Ophthalmic device
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Aug 1987
Decision
118d
Days
Class 2
Risk

K871473 is an FDA 510(k) clearance for the PART #860065 IA PAK & PART #860060 IA PAK. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Medical Technical Products (Irvine, US). The FDA issued a Cleared decision on August 10, 1987 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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.

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Submission Details

510(k) Number K871473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1987
Decision Date August 10, 1987
Days to Decision 118 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 110d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 99
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