Cleared Traditional

K142715 - Sensor Medical Family of Vitrectomy Len...

K142715 is the FDA 510(k) clearance for Sensor Medical Family of Vitrectomy Len... by Sensor Medical Technology, LLC. It is a Class 2 Ophthalmic device (product code HJK) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K142715 · Sensor Medical Technology, LLC · Ophthalmic device
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Dec 2014
Decision
85d
Days
Class 2
Risk

K142715 is an FDA 510(k) clearance for the Sensor Medical Family of Vitrectomy Lenses and Products. Classified as Lens, Contact, Polymethylmethacrylate, Diagnostic (product code HJK), Class II - Special Controls.

Submitted by Sensor Medical Technology, LLC (Maple Valley, US). The FDA issued a Cleared decision on December 16, 2014 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1385 - 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 Sensor Medical Technology, LLC devices

Submission Details

510(k) Number K142715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2014
Decision Date December 16, 2014
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1385
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 - HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

All 28
Devices cleared under the same product code (HJK) and FDA review panel - the closest regulatory comparables to K142715.
RxSight Contact Lens
K201909 · Rxsight, Inc. · Sep 2020
Endocular Viewing Lenses and Silicone Ring
K173944 · Phakos · Oct 2018
STAURENGHI WIDE FIELD SCANNING LASER LENS
K014170 · Ocular Instruments, Inc. · Mar 2002
DISPOSABLE VITRECTOMY LENS
K012096 · Ocular Instruments, Inc. · Aug 2001
MANDELKORN SUTURE LYSIS LENS
K933976 · Ocular Instruments, Inc. · Nov 1994
RITCH NYLON SUTURE LASER LENS
K933264 · Ocular Instruments, Inc. · Oct 1994