Glaucoma Module
FDA 510(k) K200954 · Topcon Healthcare Solutions, Inc.
510(k) numberK200954
Submission
- Device name
- Glaucoma Module
- Applicant
- Topcon Healthcare Solutions, Inc.
Oakland, NJ, US - Received
- April 9, 2020
- Decision date
- August 3, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NFJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260694 | Zeiss Clinic 360NFJ · Traditional | Carl Zeiss Meditec, AG | 07/17/2026SE |
| K253893 | Harmony Referral System with Harmony OCT Viewer (Octave)NFJ · Traditional | Topcon Healthcare Solutions EMEA Oy | 06/04/2026SE |
| K234076 | iCare ALTIUS CWNFJ · Traditional | Centervue S.P.A. | 08/22/2024SE |
| K232828 | IMAGEnet6 Ophthalmic Data SystemNFJ · Traditional | Topcon Corporation | 03/01/2024SE |
| K232944 | CALLISTO eyeNFJ · Special | Carl Zeiss Meditec, AG | 12/21/2023SE |
| K232555 | HarmonyNFJ · Special | Topcon Healthcare Solutions | 11/20/2023SE |
| K231676 | CALLISTO eyeNFJ · Traditional | Carl Zeiss Meditec, AG | 08/28/2023SE |
| K232088 | Altris IMSNFJ · Traditional | Altris, Inc. | 07/31/2023SE |
| K220929 | ExcelsiorNFJ · Traditional | Merit Cro, Inc. | 10/31/2022SE |
| K213527 | ForumNFJ · Traditional | Carl Zeiss Meditec, AG | 08/15/2022SE |
More from Carl Zeiss Meditec, AG
| 510(k) | Device | Decision |
|---|---|---|
| K232555 | HarmonyNFJ · Special | 11/20/2023SE |
Questions and answers
When was Glaucoma Module cleared by the FDA?
Glaucoma Module (K200954) received a 510(k) decision of Substantially Equivalent on August 3, 2020, 116 days after the submission was received.
What is the product code of K200954?
The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.