Cleared Traditional

K813313 - BIOMICROSCOPY CONTACT LENS

K813313 is an FDA 510(k) clearance for BIOMICROSCOPY CONTACT LENS, manufactured by Design Research Assoc., Inc.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K813313 · Design Research Assoc., Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1982
Decision
97d
Days
Class 2
Risk

K813313 is an FDA 510(k) clearance for the BIOMICROSCOPY CONTACT LENS. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Design Research Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1982 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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.

FDA 510(k) Submission Details - K813313

510(k) Number K813313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1981
Decision Date March 01, 1982
Days to Decision 97 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 110d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJO Device Classification - Class 2, Special Controls

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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 - HJO Biomicroscope, Slit-lamp, Ac-powered

All 105
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K813313.
BAUSCH & LOMB PSL-3000 SLIT LAMP
K862520 · Bausch & Lomb, Inc. · Jul 1986
ZEISS 30 SL-L
K862004 · Carl Zeiss, Inc. · Jun 1986
MICROSCOPE MITTS SUPPORT TRAY COVER
K842859 · Chiron Vision Corp. · Oct 1984
COHERENT FLOUROTRON MASTER
K811153 · Lumenis, Inc. · Jun 1981
KEELER/KONAN SPECULAR MICROSCOPE
K810403 · Keeler Optical Products , Ltd. · May 1981
K813313 · BIOMICROSCOPY CONTACT LENS
Download PDF Design Research Assoc…