HQF — Laser, Ophthalmic Class II
FDA Device Classification
Classification Details
- Product Code
- HQF
- Device Class
- Class II
- Regulation Number
- 886.4390
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251507 | quantel medical | INTEGRE LIO | February 6, 2026 |
| K251772 | od-os | Navilas Laser System 577sl (156691) | October 29, 2025 |
| K243014 | eyeq | EyeQ nanoECP | June 18, 2025 |
| K240615 | beaver-visitec international | Leos Laser and Endoscopy System | April 3, 2025 |
| K242397 | norlase aps | LYNX Photocoagulator | October 25, 2024 |
| K233911 | carl zeiss meditec | VISULAS combi | September 6, 2024 |
| K232417 | meridian | MR Q; MR Q SUPINE; MR Q SLT | January 25, 2024 |
| K230722 | belkin vision | Eagle device | December 8, 2023 |
| K232051 | carl zeiss meditec | VISULAS green | October 24, 2023 |
| K230350 | carl zeiss meditec | VISULAS yag | September 22, 2023 |
| K231011 | meridian | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | September 12, 2023 |
| K230228 | iridex corporation | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | February 23, 2023 |
| K220974 | lutronic vision | R:GEN | December 27, 2022 |
| K223132 | iridex corporation | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | November 9, 2022 |
| K222395 | ellex medical pty | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | November 2, 2022 |
| K222157 | norlase | ECHO Photocoagulator | October 11, 2022 |
| K220877 | lumenis be | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | July 15, 2022 |
| K220430 | quantel medical | Capsulo | May 12, 2022 |
| K213592 | iridex corporation | Iridex 810 Laser | March 23, 2022 |
| K212630 | ellex medical pty | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | December 16, 2021 |