Cleared Traditional

K961805 - TOMEY DTL ELECTRODE

K961805 is an FDA 510(k) clearance for TOMEY DTL ELECTRODE, manufactured by Tomey Corporation USA. The device is a Class 2 Ophthalmic device with product code HLZ cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K961805 · Tomey Corporation USA · Ophthalmic device
Download Printable Device Report (PDF)
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May 1997
Decision
364d
Days
Class 2
Risk

K961805 is an FDA 510(k) clearance for the TOMEY DTL ELECTRODE. Classified as Electrode, Corneal (product code HLZ), Class II - Special Controls.

Submitted by Tomey Corporation USA (Cambridge, US). The FDA issued a Cleared decision on May 9, 1997 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1220 - 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. Elevated predicate reliance 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 Tomey Corporation USA devices

FDA 510(k) Submission Details - K961805

510(k) Number K961805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1996
Decision Date May 09, 1997
Days to Decision 364 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
254d slower than avg
Panel avg: 110d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLZ Device Classification - Class 2, Special Controls

Product Code HLZ Electrode, Corneal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1220
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 - HLZ Electrode, Corneal

Devices cleared under the same product code (HLZ) and FDA review panel - the closest regulatory comparables to K961805.
RM Electrode (RMH 25-01)
K253586 · Retmap, Inc. · Apr 2026
RM Electrode (RMH 23-01)
K232273 · Retmap, Inc. · Dec 2023
SOPHER AND BIERER OVUM FORCEPS
K926540 · Thomasville Medical Assoc. · Feb 1994
GOLD FOIL ERG ELECTRODES
K820254 · Cadwell Laboratories, Inc. · Apr 1982
ERG-JET ELECTRODE
K813399 · Nicolet Biomedical Instruments · Jan 1982
MULAR GOLD LEAF ELECTRODE MODEL 7501
K781476 · Life-Tech Instruments, Inc. · Nov 1978