VISULAS yag
FDA 510(k) clearance K230350 · decided 2023-09-22
Clearance details
- K-number
- K230350
- Device name
- VISULAS yag
- Applicant
- Carl Zeiss Meditec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-02-09
- Decision date
- 2023-09-22
- Days to decision
- 225 days
- Clearance type
- Traditional
- Product code
- HQF
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Dublin, CA, US
- 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 |
| VISULAS combi (K233911) | Carl Zeiss Meditec, AG | 2024-09-06 |
| 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 |
| 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 |
|---|---|---|
| VisuMax; VISUMAX 800 (P150040/S020) | Carl Zeiss Meditec, Inc. | 2025-12-18 |
| VISUMAX 800 Femtosecond Laser (P150040/S023) | Carl Zeiss Meditec, Inc. | 2025-10-16 |
| Visumax; VISUMAX 800 (P150040/S021) | Carl Zeiss Meditec, Inc. | 2025-08-21 |
| MEL 90 EXCIMER LASER SYSTEM (P060004/S009) | Carl Zeiss Meditec, Inc. | 2025-05-23 |
| MEL90 (P060004/S006) | Carl Zeiss Meditec, Inc. | 2024-12-04 |
| VisuMax Femtosecond Laser (P150040/S018) | Carl Zeiss Meditec, Inc. | 2024-10-16 |
| VisuMax (P150040/S016) | Carl Zeiss Meditec, Inc. | 2024-10-11 |
| VisuMax (P150040/S017) | Carl Zeiss Meditec, Inc. | 2024-05-23 |