Cleared Traditional

K874355 - OPACITY LENSMETER 701

K874355 is the FDA 510(k) clearance for OPACITY LENSMETER 701 by Intraoptics, Inc.. It is a Class 2 Ophthalmic device (product code HKI) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K874355 · Intraoptics, Inc. · Ophthalmic device
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Jan 1988
Decision
95d
Days
Class 2
Risk

K874355 is an FDA 510(k) clearance for the OPACITY LENSMETER 701. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Intraoptics, Inc. (Huntington, US). The FDA issued a Cleared decision on January 26, 1988 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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 Intraoptics, Inc. devices

Submission Details

510(k) Number K874355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1987
Decision Date January 26, 1988
Days to Decision 95 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 110d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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 - HKI Camera, Ophthalmic, Ac-powered

All 59
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K874355.
CANDELA RETINAL CAMERA
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NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
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NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
K895474 · Canon USA, Inc. · Oct 1989
MODIFIED RETINAL CAMERA MODEL CR4-45NM
K874017 · Canon USA, Inc. · Nov 1987
CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
K862323 · Canon USA, Inc. · Aug 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
K855170 · Canon USA, Inc. · Feb 1986