Confoscan
FDA 510(k) K971953 · Tomey Corporation USA
510(k) numberK971953
Submission
- Device name
- Confoscan
- Applicant
- Tomey Corporation USA
Cambridge, MA, US - Received
- May 28, 1997
- Decision date
- August 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K971685 | Imagescape Digital Retinal Image SystemHKI · Traditional | 06/24/1997SE |
| K961805 | Tomey DTL ElectrodeHLZ · Traditional | 05/09/1997SE |
| K932571 | Tomey PE-400 Portable Erg & Vep with Optional PS-4GWE · Traditional | 08/31/1995SE |
| K945959 | Video Vision Analyzer (Viva), VRB 100HKO · Traditional | 03/01/1995SE |
| K944910 | Tomey EM-1000 Specular MicroscopeHJO · Traditional | 11/22/1994SE |
| K924760 | Tomey Proton TonometerHKY · Traditional | 04/05/1993SE |
| K921815 | Tomey PE-300 Portable ErgHLT · Traditional | 07/15/1992SE |
| K912112 | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480LQJ · Traditional | 06/17/1991SE |
Questions and answers
When was Confoscan cleared by the FDA?
Confoscan (K971953) received a 510(k) decision of Substantially Equivalent on August 14, 1997, 78 days after the submission was received.
What is the product code of K971953?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.