Cleared Traditional

K860205 - BIO-PEN CALCULATOR (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K860205 · Oculab, Inc. · Ophthalmic device
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Apr 1986
Decision
92d
Days
Class 3
Risk

K860205 is an FDA 510(k) clearance for the BIO-PEN CALCULATOR. Classified as Medical Computers And Software For Ophthalmic Use (product code LQB), Class III - Premarket Approval.

Submitted by Oculab, Inc. (Gendale, US). The FDA issued a Cleared decision on April 24, 1986 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. 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 Oculab, Inc. devices

Submission Details

510(k) Number K860205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1986
Decision Date April 24, 1986
Days to Decision 92 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 110d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQB Medical Computers And Software For Ophthalmic Use
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.