HQF — Laser, Ophthalmic Class II
FDA product code HQF covers "Laser, Ophthalmic", a Class II medical device regulated under 21 CFR 886.4390. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K252979 | belkin vision | Voyager DSLT (430840610) | April 7, 2026 |
| 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 |