Laser Flare Meter
FDA 510(k) K913852 · Kowa Optimed, Inc.
510(k) numberK913852
Submission
- Device name
- Laser Flare Meter
- Applicant
- Kowa Optimed, Inc.
Torrance, CA, US - Received
- August 27, 1991
- Decision date
- February 7, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HJO – Biomicroscope, Slit-Lamp, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Specialty
- Ophthalmic
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|---|---|---|---|
| K253834 | Visuref 600HJO · Traditional | Carl Zeiss Vision GmbH | 03/18/2026SE |
| K231760 | Hp-Oct (Hp-Oct)HJO · Traditional | Cylite Pty. , Ltd. | 03/08/2024SE |
| K222372 | Kowa SL-19HJO · Traditional | Kowa Company , Ltd. | 11/21/2022SE |
| K193188 | MiiS Horus Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 01/14/2020SE |
| K182306 | Sunkingdom Slit LampHJO · Traditional | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 11/22/2018SE |
| K173771 | IOLMaster 700HJO · Traditional | Carl Zeiss Meditec, AG | 08/24/2018SE |
| K171877 | SLM-1ER, SLM-2ER, SLM-3ERHJO · Traditional | Chongqing Kanghua Ruiming S&T Co., Ltd. | 12/21/2017SE |
| K170470 | Digital Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 10/06/2017SE |
| K162778 | Portable Slit Lamp MicroscopeHJO · Traditional | Suzhou Kangjie Medical, Inc. | 07/21/2017SE |
| K162684 | SL 220HJO · Traditional | Carl Zeiss Meditec, AG | 05/31/2017SE |
More from Carl Zeiss Meditec, AG
| 510(k) | Device | Decision |
|---|---|---|
| K013805 | Kowa Automated Tonometer KT-500HKX · Traditional | 10/11/2002SE |
| K961090 | Automatic Visual Field Plotter AP-125HPT · Traditional | 06/17/1996SE |
| K960924 | Kowa Hand-Held Applanation Tonometer HA-1HKY · Traditional | 06/04/1996SE |
| K955442 | Kowa SC-1200 Photo Slit Lamp SystemHKI · Traditional | 01/03/1996SE |
| K954781 | Kowa Genesis Hand-Held Fundus CameraHKI · Traditional | 12/01/1995SE |
| K954780 | Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500CHKI · Traditional | 12/01/1995SE |
| K954782 | Kowa Portable Slit Lamp SL-14 & SL-14BHJO · Traditional | 11/24/1995SE |
| K880920 | Laser Flare Cell Meter FC-1000HJO · Traditional | 09/27/1988SE |
| K881219 | Automatic Perimeter, AP-340HPT · Traditional | 05/03/1988SE |
Questions and answers
When was Laser Flare Meter cleared by the FDA?
Laser Flare Meter (K913852) received a 510(k) decision of Substantially Equivalent on February 7, 1992, 164 days after the submission was received.
What is the product code of K913852?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.