Cleared Traditional

K852075 - SITE-MALIS BIPOLAR COAGULATOR MODULE (FDA 510(k) Clearance)

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

K852075 · Valley Forge Scientific Corp. · Ophthalmic device
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Aug 1985
Decision
99d
Days
Class 2
Risk

K852075 is an FDA 510(k) clearance for the SITE-MALIS BIPOLAR COAGULATOR MODULE. Classified as Unit, Cautery, Thermal, Ac-powered (product code HQO), Class II - Special Controls.

Submitted by Valley Forge Scientific Corp. (Valley Forge, US). The FDA issued a Cleared decision on August 20, 1985 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4115 - 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 Valley Forge Scientific Corp. devices

Submission Details

510(k) Number K852075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1985
Decision Date August 20, 1985
Days to Decision 99 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 110d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQO Unit, Cautery, Thermal, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4115
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.