Cleared Traditional

K874355 - OPACITY LENSMETER 701

K874355 is an FDA 510(k) clearance for OPACITY LENSMETER 701, manufactured by Intraoptics, Inc.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K874355

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.

HKI Device Classification - Class 2, Special Controls

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 114
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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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