Kowa Optimed, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 10
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Kowa Optimed, Inc. makes
Kowa Optimed, Inc. manufactures ophthalmic diagnostic devices, including automatic visual field plotters, handheld applanation tonometers, slit lamp systems, fundus cameras, laser flare meters, and automated tonometers. Their product line also includes portable slit lamps and automated perimeter devices designed for eye examination and intraocular pressure measurement.
The company’s devices are regulated under FDA Class I and Class II classifications, with several products listed via the 510(k) pathway. These instruments are intended for use in clinical settings and are based in the United States.
Catalogue
Automatic Visual Field Plotter Ap-125 Ref K961090
510(k) 510(k)Kowa Hand-Held Applanation Tonometer Ha-1 Ref K960924
510(k) 510(k)Kowa Sc-1200 Photo Slit Lamp System Ref K955442
510(k) 510(k)Kowa Genesis Hand-Held Fundus Camera Ref K954781
510(k) 510(k)Laser Flare Cell Meter Fc-1000 Ref K880920
510(k) 510(k)- 510(k) 510(k)
Automatic Perimeter, Ap-340 Ref K881219
510(k) 510(k)Kowa Portable Slit Lamp Sl-14 & Sl-14B Ref K954782
510(k) 510(k)Laser Flare Meter Ref K913852
510(k) 510(k)Kowa Automated Tonometer Kt-500 Ref K013805
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Kowa Optimed, Inc., initiated on 2020-11-03. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 1
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 3 Nov 2020 Z-0636-2021 Class II Terminated It has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the same time, their is a potential for all patient information to be deleted. This could result in delay of treatment.
Frequently asked questions
How many devices does Kowa Optimed, Inc. have in the registry?
The registry currently lists 10 devices for Kowa Optimed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kowa Optimed, Inc.'s devices?
Among its 10 most recently registered devices, Kowa Optimed, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Kowa Optimed, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Kowa Optimed, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Kowa Optimed, Inc.?
FDA recall records list 1 recall initiated by Kowa Optimed, Inc., the most recent initiated on 2020-11-03. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Kowa Optimed, Inc. in the registry?
The most recently registered devices listed for Kowa Optimed, Inc. include AUTOMATIC VISUAL FIELD PLOTTER AP-125, KOWA HAND-HELD APPLANATION TONOMETER HA-1, KOWA SC-1200 PHOTO SLIT LAMP SYSTEM and KOWA GENESIS HAND-HELD FUNDUS CAMERA.