Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4690](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4690) → HQB — Photocoagulator And Accessories # HQB · Photocoagulator And Accessories _Ophthalmic · 21 CFR 886.4690 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB ## Overview - **Product Code:** HQB - **Device Name:** Photocoagulator And Accessories - **Regulation:** [21 CFR 886.4690](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4690) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **3rd-party reviewable:** yes ## Identification An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 30) Showing 20 most recent of 30 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K220263](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K220263.md) | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers | Vortex Surgical, Inc. | Nov 3, 2022 | SESE | | [K191846](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K191846.md) | MAXReach Laser Probe | Vortex Surgical, Inc. | Dec 23, 2019 | SESE | | [K182646](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K182646.md) | Vitreq disposable laser probes, light fibers and Chandelier | VitreQ BV | May 1, 2019 | SESE | | [K132614](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K132614.md) | PEREGRINE CURVED ILLUMINATING LASER PROBE | Peregrine Surgical , Ltd. | Nov 14, 2013 | SESE | | [K122997](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K122997.md) | 23GA CURVED ILLUMINATING LASER PROBE | Peregrine Surgical , Ltd. | Jun 26, 2013 | SESE | | [K122905](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K122905.md) | PEREGRINE 23GA CURVED LASER PROBE | Peregrine Surgical , Ltd. | Apr 30, 2013 | SESE | | [K113857](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K113857.md) | SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE | Synergetics, Inc. | Apr 23, 2012 | SESE | | [K110951](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K110951.md) | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA | Alcon Research, Ltd. | Oct 17, 2011 | SESE | | [K111493](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K111493.md) | NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI | Nidek Co., Ltd. | Jul 27, 2011 | SESE | | [K110228](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K110228.md) | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR | Nidek Incorporated | Feb 23, 2011 | SESE | | [K964380](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K964380.md) | LC-250 INFRARED LIGHT COAGULATOR | Nk-Optik America | Jan 22, 1997 | SESE | | [K954308](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K954308.md) | GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE | Gamp & Assoc. | Dec 22, 1995 | SESE | | [K954307](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K954307.md) | GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE | Gamp & Assoc. | Dec 22, 1995 | SESE | | [K954306](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K954306.md) | GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE | Gamp & Assoc. | Dec 22, 1995 | SESE | | [K923531](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K923531.md) | OPTOSCALPEL I LASER SYSTEM | Optomed Corp. | Nov 12, 1993 | SESE | | [K924090](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K924090.md) | THE ENDO OPTIKS MICROPROBE | Endo Optics, Inc. | Feb 1, 1993 | SESE | | [K922735](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K922735.md) | ZIESS ENDOPROBE | Carl Zeiss, Inc. | Jul 9, 1992 | SESE | | [K882679](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K882679.md) | SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION | Surgical Laser Technologies, Inc. | Dec 14, 1988 | SESE | | [K882441](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K882441.md) | SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION | Surgical Laser Technologies, Inc. | Sep 26, 1988 | SESE | | [K881926](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB/K881926.md) | REUSABLE FIBEROPTIC LIGHTPIPE | Advanced Surgical Products, Inc. | Jun 6, 1988 | SESE | ## Top Applicants - Gamp & Assoc. — 3 clearances - Nidek, Inc. — 3 clearances - Peregrine Surgical , Ltd. — 3 clearances - Cavitron Corp. — 2 clearances - Surgical Laser Technologies, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com