VISULAS combi
FDA 510(k) K233911 · Carl Zeiss Meditec, AG
510(k) numberK233911
Submission
- Device name
- VISULAS combi
- Applicant
- Carl Zeiss Meditec, AG
Jena, DE - Received
- December 12, 2023
- Decision date
- September 6, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQF – Laser, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
Other 510(k)s with product code HQF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252979 | Voyager DSLT (430840610)HQF · Traditional | Belkin Vision, Ltd. | 04/07/2026SE |
| K251507 | Integre LioHQF · Traditional | Quantel Medical | 02/06/2026SE |
| K251772 | Navilas Laser System 577sl (156691)HQF · Traditional | Od-Os GmbH | 10/29/2025SE |
| K243014 | EyeQ nanoECPHQF · Traditional | Eyeq, Inc. | 06/18/2025SE |
| K240615 | Leos Laser and Endoscopy SystemHQF · Traditional | Beaver-Visitec International, Inc. | 04/03/2025SE |
| K242397 | LYNX PhotocoagulatorHQF · Traditional | Norlase Aps | 10/25/2024SE |
| K232417 | MR Q; MR Q Supine; MR Q SLTHQF · Traditional | Meridian AG | 01/25/2024SE |
| K230722 | Eagle deviceHQF · Traditional | Belkin Vision, Ltd. | 12/08/2023SE |
| K232051 | VISULAS greenHQF · Traditional | Carl Zeiss Meditec | 10/24/2023SE |
| K230350 | VISULAS yagHQF · Traditional | Carl Zeiss Meditec, Inc. | 09/22/2023SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K260694 | Zeiss Clinic 360NFJ · Traditional | 07/17/2026SE |
| K243878 | Clarus (700)QER · Traditional | 04/17/2025SE |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…JAD · Traditional | 01/10/2025SE |
| K240215 | Blue 400; Blue 400 SQFX · Traditional | 06/28/2024SE |
| K233933 | CIRRUS HD-OCT Model 6000OBO · Traditional | 05/17/2024SE |
| K233421 | Rescan 700OBO · Traditional | 03/08/2024SE |
| K232944 | CALLISTO eyeNFJ · Special | 12/21/2023SE |
| K232051 | VISULAS greenHQF · Traditional | 10/24/2023SE |
| K230350 | VISULAS yagHQF · Traditional | 09/22/2023SE |
| K232159 | QEVO SystemGWG · Special | 09/21/2023SE |
Questions and answers
When was VISULAS combi cleared by the FDA?
VISULAS combi (K233911) received a 510(k) decision of Substantially Equivalent on September 6, 2024, 269 days after the submission was received.
What is the product code of K233911?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.