Cleared Traditional

DIATHRON(R) DIATHERMY UNIT (K894513) - FDA 510(k) Clearance

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

K894513 · Intl. Ophthalmic Industries Corp. · Ophthalmic device
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Oct 1989
Decision
104d
Days
Class 2
Risk

K894513 is an FDA 510(k) clearance for the DIATHRON(R) DIATHERMY UNIT. Classified as Transilluminator, Ac-powered (product code HJM), Class II - Special Controls.

Submitted by Intl. Ophthalmic Industries Corp. (Weston, US). The FDA issued a Cleared decision on October 31, 1989 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1945 - 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 Intl. Ophthalmic Industries Corp. devices

Submission Details

510(k) Number K894513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1989
Decision Date October 31, 1989
Days to Decision 104 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 110d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HJM Transilluminator, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1945
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.