Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4390](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4390) → HQF — Laser, Ophthalmic # HQF · Laser, Ophthalmic _Ophthalmic · 21 CFR 886.4390 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF ## Overview - **Product Code:** HQF - **Device Name:** Laser, Ophthalmic - **Regulation:** [21 CFR 886.4390](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4390) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **3rd-party reviewable:** yes ## Identification An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 180) Showing 20 most recent of 180 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252979](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K252979.md) | Voyager DSLT (430840610) | Belkin Vision, Ltd. | Apr 7, 2026 | SESE | | [K251507](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K251507.md) | INTEGRE LIO | Quantel Medical | Feb 6, 2026 | SESE | | [K251772](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K251772.md) | Navilas Laser System 577sl (156691) | Od-Os GmbH | Oct 29, 2025 | SESE | | [K243014](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K243014.md) | EyeQ nanoECP | Eyeq, Inc. | Jun 18, 2025 | SESE | | [K240615](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K240615.md) | Leos Laser and Endoscopy System | Beaver-Visitec International, Inc. | Apr 3, 2025 | SESE | | [K242397](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K242397.md) | LYNX Photocoagulator | Norlase Aps | Oct 25, 2024 | SESE | | [K233911](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K233911.md) | VISULAS combi | Carl Zeiss Meditec, AG | Sep 6, 2024 | SESE | | [K232417](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K232417.md) | MR Q; MR Q SUPINE; MR Q SLT | Meridian AG | Jan 25, 2024 | SESE | | [K230722](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K230722.md) | Eagle device | Belkin Vision, Ltd. | Dec 8, 2023 | SESE | | [K232051](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K232051.md) | VISULAS green | Carl Zeiss Meditec | Oct 24, 2023 | SESE | | [K230350](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K230350.md) | VISULAS yag | Carl Zeiss Meditec, Inc. | Sep 22, 2023 | SESE | | [K231011](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K231011.md) | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | Meridian AG | Sep 12, 2023 | SESE | | [K230228](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K230228.md) | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | Iridex Corporation | Feb 23, 2023 | SESE | | [K220974](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K220974.md) | R:GEN | Lutronic Vision, Inc. | Dec 27, 2022 | SESE | | [K223132](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K223132.md) | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | Iridex Corporation | Nov 9, 2022 | SESE | | [K222395](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K222395.md) | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | Ellex Medical Pty, Ltd. | Nov 2, 2022 | SESE | | [K222157](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K222157.md) | ECHO Photocoagulator | Norlase | Oct 11, 2022 | SESE | | [K220877](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K220877.md) | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | Lumenis Be, Inc. | Jul 15, 2022 | SESE | | [K220430](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K220430.md) | Capsulo | Quantel Medical | May 12, 2022 | SESE | | [K213592](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K213592.md) | Iridex 810 Laser | Iridex Corporation | Mar 23, 2022 | SESE | ## Top Applicants - Quantel Medical — 13 clearances - Lightmed Corp. — 9 clearances - Nidek, Inc. — 8 clearances - Ellex Medical Pty, Ltd. — 8 clearances - Hgm, Inc. — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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