Novavision, Model 2.0

Q: What is the product code of K023623?

The FDA product code is HPT – Perimeter, Automatic, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1605.

FDA 510(k) K023623 · Novavision, Inc.

Substantially Equivalent

510(k) numberK023623

Submission

Device name: Novavision, Model 2.0
Applicant: Novavision, Inc.
Washington, DC, US
Received: October 29, 2002
Decision date: April 22, 2003
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HPT – Perimeter, Automatic, Ac-Powered
Device class: Class I (low risk)
Regulation: 21 CFR 886.1605
Specialty: Ophthalmic

Other 510(k)s with product code HPT

510(k)	Device	Applicant	Decision
K092187	Maia, Model 1HPT · Traditional	Centervue S.P.A.	05/27/2010SE
K093213	Guided Progression Analysis on the Humphrey Field Analyzer II and II -I SeriesHPT · Traditional	Carl Zeiss Meditec, Inc.	03/12/2010SE
K091579	Foresee HomeHPT · Traditional	Notal Vision , Ltd.	12/23/2009SE
K063310	Truefield AnalyzerHPT · Traditional	Seeing Machines Limited	08/02/2007SE
K050350	The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP)HPT · Traditional	Notal Vision, Inc.	04/29/2005SE
K971156	Kasha Visual Field SystemHPT · Traditional	Kasha Software, Inc.	05/28/1997SE
K961090	Automatic Visual Field Plotter AP-125HPT · Traditional	Kowa Optimed, Inc.	06/17/1996SE
K954167	Humphrey Field Analyzer (Hfa II)HPT · Traditional	Carl Zeiss, Inc.	11/24/1995SE
K954037	Field TrendHPT · Traditional	Synemed, Inc.	11/17/1995SE
K943234	MS-30 Automatic PerimeterHPT · Traditional	Marco Ophthalmic, Inc.	07/27/1994SE

More from Marco Ophthalmic, Inc.

510(k)	Device	Decision
K960584	Novanew Reconditioning System for Prof. Use In-Office Use OnlyHQD · Traditional	08/15/1996SE
K955900	Novalens/Novawet Sphjerical & Perception & Vanguard Multifocal &/Or Bifocal (Rosifocon…HQD · Traditional	03/25/1996SE

Questions and answers

When was Novavision, Model 2.0 cleared by the FDA?

Novavision, Model 2.0 (K023623) received a 510(k) decision of Substantially Equivalent on April 22, 2003, 175 days after the submission was received.

What is the product code of K023623?

The FDA product code is HPT – Perimeter, Automatic, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1605.