Cleared Traditional

K862713 - ABRAHAM IRIDECTOMY LENS (YAG LASER)

K862713 is the FDA 510(k) clearance for ABRAHAM IRIDECTOMY LENS (YAG LASER) by Ocular Instruments, Inc.. It is a Class 1 Ophthalmic device (product code HKS) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K862713 · Ocular Instruments, Inc. · Ophthalmic device
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Aug 1986
Decision
36d
Days
Class 1
Risk

K862713 is an FDA 510(k) clearance for the ABRAHAM IRIDECTOMY LENS (YAG LASER). Classified as Prism, Gonioscopic (product code HKS), Class I - General Controls.

Submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on August 21, 1986 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ocular Instruments, Inc. devices

Submission Details

510(k) Number K862713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1986
Decision Date August 21, 1986
Days to Decision 36 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
74d faster than avg
Panel avg: 110d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKS Prism, Gonioscopic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HKS Prism, Gonioscopic

All 7
Devices cleared under the same product code (HKS) and FDA review panel - the closest regulatory comparables to K862713.
TWO MIRROR GONIO LENS
K895846 · Ocular Instruments, Inc. · Dec 1989
MCINTYRE SURGICAL GONIOLENS
K890977 · Ocular Instruments, Inc. · May 1989
KARICKHOFF DIAGNOSTIC/LASER LENS
K862692 · Ocular Instruments, Inc. · Aug 1986
SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM
K862024 · Ocular Instruments, Inc. · Jul 1986
RITCH TRABECULOPLASTY LASER LENS
K862512 · Ocular Instruments, Inc. · Jul 1986
DORC ADJUSTABLE IMAGE CONTACTS
K830169 · Jedmed Instrument Co. · Feb 1983