Cleared Traditional

K142715 - Sensor Medical Family of Vitrectomy Lenses and Products

K142715 is an FDA 510(k) clearance for Sensor Medical Family of Vitrectomy Len..., manufactured by Sensor Medical Technology, LLC. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K142715

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
Combination Product No
PCCP Authorized No
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.

HJK Device Classification - Class 2, Special Controls

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 Consultant

O’Connell Regulatory Consultants, Inc.
Maureen O'Connell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

All 33
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
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
K151961 · Volk Optical, Inc. · Aug 2015
SUPER VIEW DISPOSABLE BIOM LENS SET
K051630 · Insight Instruments, Inc. · Jun 2005
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
K051103 · Haag-Streit USA, Inc. · Jun 2005
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
K050623 · Volk Optical, Inc. · Mar 2005