Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1570](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1570) → MYC — Ophthalmoscope, Laser, Scanning # MYC · Ophthalmoscope, Laser, Scanning _Ophthalmic · 21 CFR 886.1570 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC ## Overview - **Product Code:** MYC - **Device Name:** Ophthalmoscope, Laser, Scanning - **Regulation:** [21 CFR 886.1570](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1570) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **3rd-party reviewable:** yes ## Identification An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye. ## Classification Rationale Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. ## Special Controls *Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. ## Recent Cleared Devices (20 of 22) Showing 20 most recent of 22 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K241931](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K241931.md) | OcuMet Beacon (OCUB100) | Ocusciences, Inc. | Apr 22, 2025 | SESE | | [K243504](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K243504.md) | MAIA (AHMACME001) | Centervue S.P.A. | Mar 17, 2025 | SESE | | [K213705](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K213705.md) | DRSplus | Centervue S.P.A. | Dec 21, 2021 | SESE | | [K211328](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K211328.md) | EIDON FA, EIDON, EIDON AF, EIDON UWFL | Centervue S.P.A. | Aug 19, 2021 | SESE | | [K192113](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K192113.md) | DRSplus | Centervue S.P.A. | Nov 15, 2019 | SESE | | [K180526](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K180526.md) | EIDON FA | Centervue S.P.A. | Jul 16, 2018 | SESE | | [K180293](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K180293.md) | Retia 2 | Centervue S.P.A. | May 30, 2018 | SESE | | [K153181](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K153181.md) | MAIA | Centervue S.P.A. | Jun 8, 2016 | SESE | | [K150320](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K150320.md) | COMPASS | Centervue S.P.A. | Jun 30, 2015 | SESE | | [K142897](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K142897.md) | P200DTx | Optos Plc. | Jan 16, 2015 | SESE | | [K142047](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K142047.md) | EIDON | Centervue S.P.A. | Nov 12, 2014 | SESE | | [K134039](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K134039.md) | DAYTONA ICG (P200TICG) | Optos Plc. | Apr 11, 2014 | SESE | | [K112880](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K112880.md) | CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE | Freedom Meditech, Inc. | Jan 31, 2013 | SESE | | [K111988](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K111988.md) | EASYSCAN MODEL 1.2 | I-Optics BV | Oct 28, 2011 | SESE | | [K111628](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K111628.md) | P200T | Optos Plc. | Aug 19, 2011 | SESE | | [K102492](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K102492.md) | P200MAAF | Optos Plc. | Sep 30, 2010 | SESE | | [K100644](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K100644.md) | OPTOS LIMITED PANORAMIC 200CAF | Optos Plc. | Jul 15, 2010 | SESE | | [K093521](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K093521.md) | GDXPRO | Carl Zeiss Meditec, Inc. | Nov 25, 2009 | SESE | | [K082016](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K082016.md) | GDX VCC WITH ECC SOFTWARE | Carl Zeiss Meditec, Inc. | Aug 10, 2009 | SESE | | [K091039](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC/K091039.md) | KOWA, FM-600, MODEL LSS50 | Kowa Co. , Ltd. | Aug 7, 2009 | SESE | ## Top Applicants - Centervue S.P.A. — 9 clearances - Optos Plc. — 6 clearances - Carl Zeiss Meditec, Inc. — 2 clearances - Freedom Meditech, Inc. — 1 clearance - I-Optics BV — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MYC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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