VISULAS combi
FDA 510(k) clearance K233911 · decided 2024-09-06
Clearance details
- K-number
- K233911
- Device name
- VISULAS combi
- Applicant
- Carl Zeiss Meditec, AG
- Decision
- Substantially Equivalent
- Date received
- 2023-12-12
- Decision date
- 2024-09-06
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- HQF
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Jena, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Voyager DSLT (430840610) (K252979) | Belkin Vision, Ltd. | 2026-04-07 |
| INTEGRE LIO (K251507) | Quantel Medical | 2026-02-06 |
| Navilas Laser System 577sl (156691) (K251772) | Od-Os GmbH | 2025-10-29 |
| EyeQ nanoECP (K243014) | Eyeq, Inc. | 2025-06-18 |
| Leos Laser and Endoscopy System (K240615) | Beaver-Visitec International, Inc. | 2025-04-03 |
| LYNX Photocoagulator (K242397) | Norlase Aps | 2024-10-25 |
| MR Q; MR Q SUPINE; MR Q SLT (K232417) | Meridian AG | 2024-01-25 |
| Eagle device (K230722) | Belkin Vision, Ltd. | 2023-12-08 |
| VISULAS green (K232051) | Carl Zeiss Meditec | 2023-10-24 |
| VISULAS yag (K230350) | Carl Zeiss Meditec, Inc. | 2023-09-22 |
| Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse (K231011) | Meridian AG | 2023-09-12 |
| Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) (K230228) | Iridex Corporation | 2023-02-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER (P990048/S003) | Carl Zeiss Meditec, AG | 2008-10-31 |
| VISULAS 690S AND VISULINK PDT/U ADAPTER (P990048/S001) | Carl Zeiss Meditec, AG | 2001-09-27 |
| VISULAS 690S LASER AND VISULINK PDT ADAPTER (P990048/S002) | Carl Zeiss Meditec, AG | 2001-07-03 |
| ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER (P990048) | Carl Zeiss Meditec, AG | 2000-04-12 |
| MENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES (P830056/S079) | Carl Zeiss Meditec, AG | 1999-05-11 |
| POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION) (P830056/S078) | Carl Zeiss Meditec, AG | 1998-01-29 |
| POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S077) | Carl Zeiss Meditec, AG | 1996-08-01 |
| POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S075) | Carl Zeiss Meditec, AG | 1996-04-02 |