Sensor Medical Family of Vitrectomy Lenses and Products

FDA 510(k) K142715 · Sensor Medical Technology, LLC

Substantially Equivalent

510(k) numberK142715

Submission

Device name
Sensor Medical Family of Vitrectomy Lenses and Products
Applicant
Sensor Medical Technology, LLC
Maple Valley, WA, US
Received
September 22, 2014
Decision date
December 16, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HJK – Lens, Contact, Polymethylmethacrylate, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1385
Specialty
Ophthalmic

Other 510(k)s with product code HJK

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K201909RxSight Contact LensHJK · Traditional Rxsight, Inc.09/10/2020SE
K173944Endocular Viewing Lenses and Silicone RingHJK · Traditional Phakos10/25/2018SE
K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensHJK · Special Volk Optical, Inc.08/18/2015SE
K051630Super View Disposable Biom Lens SetHJK · Traditional Insight Instruments, Inc.06/29/2005SE
K051103Haag-Streit Contact Glasses Stery Cup, AccessoryHJK · Traditional Haag-Streit USA, Inc.06/07/2005SE
K050623Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism…HJK · Special Volk Optical, Inc.03/28/2005SE
K033950Dorc Vitrectomy Lenses, Model 1284 SeriesHJK · Traditional Dutch Ophthalmic Research Center (D.O.R.C.)02/20/2004SE
K030054Disposable Vitrectomy Sets, Disposable Virectomy LensesHJK · Traditional Fci Ophthalmics, Inc.02/26/2003SE
K023221Contact Laser & Diagnostic LensesHJK · Special Volk Optical, Inc.10/11/2002SE
K022413Luneau 3 Mirror LensHJK · Traditional Luneau SA09/24/2002SE

More from Luneau SA

510(k)DeviceDecision
K152308Sensor Medical Single Use Tonometer PrismHKY · Traditional 10/13/2015SE
K140368Family of Disposable LensesHKS · Traditional 04/29/2014SE

Questions and answers

When was Sensor Medical Family of Vitrectomy Lenses and Products cleared by the FDA?

Sensor Medical Family of Vitrectomy Lenses and Products (K142715) received a 510(k) decision of Substantially Equivalent on December 16, 2014, 85 days after the submission was received.

What is the product code of K142715?

The FDA product code is HJK – Lens, Contact, Polymethylmethacrylate, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 886.1385.