HQF
- Product code
- HQF
- Device name
- Laser, Ophthalmic
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.4390
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 12
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 180 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (12)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252979 | 2026-04-07 | Belkin Vision, Ltd. | Voyager DSLT (430840610) | |
| K251507 | 2026-02-06 | Quantel Medical | INTEGRE LIO | |
| K251772 | 2025-10-29 | Od-Os GmbH | Navilas Laser System 577sl (156691) | |
| K243014 | 2025-06-18 | Eyeq, Inc. | EyeQ nanoECP | — |
| K240615 | 2025-04-03 | Beaver-Visitec International, Inc. | Leos Laser and Endoscopy System | |
| K242397 | 2024-10-25 | Norlase Aps | LYNX Photocoagulator | — |
| K233911 | 2024-09-06 | Carl Zeiss Meditec, AG | VISULAS combi | FDA |
| K232417 | 2024-01-25 | Meridian AG | MR Q; MR Q SUPINE; MR Q SLT | — |
| K230722 | 2023-12-08 | Belkin Vision, Ltd. | Eagle device | |
| K232051 | 2023-10-24 | Carl Zeiss Meditec | VISULAS green | |
| K230350 | 2023-09-22 | Carl Zeiss Meditec, Inc. | VISULAS yag | |
| K231011 | 2023-09-12 | Meridian AG | Merilas 532 shortpulse, Merilas 577 shortpulse, Meri… | — |
Official FDA classification page: HQF
Classification and pathway per current FDA publications. Data from openFDA (CC0).