Keratome System, Model K3000

FDA 510(k) K984537 · Insight Technologies Instruments, LLC

Substantially Equivalent

510(k) numberK984537

Submission

Device name
Keratome System, Model K3000
Applicant
Insight Technologies Instruments, LLC
Milford, CT, US
Received
December 21, 1998
Decision date
May 14, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HMY – Keratome, Battery-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.4370
Specialty
Ophthalmic

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K040297Oneuse- Plus MicrokeratomeHMY · Traditional Moria SA03/31/2004SE
K023092BD K-4000 Microkeratome SystemHMY · Special Becton, Dickinson & CO10/18/2002SE
K022637BD-3000 Microkeratome System, Model K-3000 MicrokeratomeHMY · Traditional Becton, Dickinson & CO10/16/2002SE
K022560M2 Single Use MicrokertomeHMY · Traditional Moria SA09/27/2002SE
K003594Carriazo Barraquer Single Use MicrokeratomeHMY · Traditional Moria, Inc.03/09/2001SE
K002191Carriazo Barraquer II MicrokeratomeHMY · Traditional Moria, Inc.10/12/2000SE
K992687Millenium Microkeratome, Model IMD-001HMY · Traditional Industrial & Medical Design, Inc.09/24/1999SE
K981741Carriazo Barraquer MicrokeratomeHMY · Traditional Moria, Inc.07/24/1998SE
K974243Keratome SystemHMY · Traditional Insight Technologies Instruments, LLC01/20/1998SE
K902857Visi-Drape Ophthalmic DrapesHMY · Traditional Visitec Co.07/31/1990SE

More from Visitec Co.

510(k)DeviceDecision
K974243Keratome SystemHMY · Traditional 01/20/1998SE

Questions and answers

When was Keratome System, Model K3000 cleared by the FDA?

Keratome System, Model K3000 (K984537) received a 510(k) decision of Substantially Equivalent on May 14, 1999, 144 days after the submission was received.

What is the product code of K984537?

The FDA product code is HMY – Keratome, Battery-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.