Keratoplasty Suturing Lens

FDA 510(k) K940106 · Visionary Technologies of Miami, Inc.

Substantially Equivalent

510(k) numberK940106

Submission

Device name
Keratoplasty Suturing Lens
Applicant
Visionary Technologies of Miami, Inc.
Miami, FL, US
Received
January 10, 1994
Decision date
May 25, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HPX – Lens, Contact (Polymethylmethacrylate)
Device class
Unclassified

Other 510(k)s with product code HPX

510(k)DeviceApplicantDecision
K955777Pmma ClasicHPX · Traditional Rand Scientific Corp.05/16/1996SE
K913081Multi-View BifocalsHPX · Traditional Camp Contact Lenses10/23/1991SE
K897021Martin-Hensley Segment LensHPX · Traditional Bruce W. Martin O.D. and Edward Hensley06/22/1990SE
K895411Optikem Pmma Contact LensHPX · Traditional Optikem Polymers, Inc.02/27/1990SE
K874591Illuminating Infusion Contact Lens for Eye SurgeryHPX · Traditional Vitreo Dynamics, Co.05/03/1988SE
K865111Charter Hard Contact Lens Cleaning SolutionHPX · Traditional Paco Pharmaceutical Services, Inc.01/20/1987SE
K864343BL1 (Hard Contact Lens)HPX · Traditional Beta Labs, Inc.11/28/1986SE
K863974Charter Laboratories Inc. Lens LubricantHPX · Traditional Paco Pharmaceutical Services, Inc.11/10/1986SE
K862952Charter Wetting Solution for Hard Contact LensesHPX · Traditional Paco Pharmaceutical Services, Inc.09/25/1986SE
K862811Aqualux Lens CaseHPX · Traditional Safeway Products, Inc.09/03/1986SE

More from Safeway Products, Inc.

510(k)DeviceDecision
K940107Virectomy LensHJK · Traditional 09/06/1994SE

Questions and answers

When was Keratoplasty Suturing Lens cleared by the FDA?

Keratoplasty Suturing Lens (K940106) received a 510(k) decision of Substantially Equivalent on May 25, 1994, 135 days after the submission was received.

What is the product code of K940106?

The FDA product code is HPX – Lens, Contact (Polymethylmethacrylate), a Unclassified device.