Cleared Traditional

K913239 - GOLDLENS(TM)

K913239 is an FDA 510(k) clearance for GOLDLENS(TM), manufactured by Doran Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HLZ cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K913239 · Doran Instruments, Inc. · Ophthalmic device
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Jan 1992
Decision
193d
Days
Class 2
Risk

K913239 is an FDA 510(k) clearance for the GOLDLENS(TM). Classified as Electrode, Corneal (product code HLZ), Class II - Special Controls.

Submitted by Doran Instruments, Inc. (Littleton, US). The FDA issued a Cleared decision on January 31, 1992 after a review of 193 days - an extended review cycle.

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. 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 Doran Instruments, Inc. devices

FDA 510(k) Submission Details - K913239

510(k) Number K913239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1991
Decision Date January 31, 1992
Days to Decision 193 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 110d · This submission: 193d
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

All 7
Devices cleared under the same product code (HLZ) and FDA review panel - the closest regulatory comparables to K913239.
RM Electrode (RMH 23-01)
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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