MYC · Ophthalmoscope, Laser, Scanning
Ophthalmic · 21 CFR 886.1570 · Class 2
Overview
| Product Code | MYC |
|---|---|
| Device Name | Ophthalmoscope, Laser, Scanning |
| Regulation | 21 CFR 886.1570 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 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 | OcuMet Beacon (OCUB100) | Ocusciences, Inc. | Apr 22, 2025 | SESE |
| K243504 | MAIA (AHMACME001) | Centervue S.P.A. | Mar 17, 2025 | SESE |
| K213705 | DRSplus | Centervue S.P.A. | Dec 21, 2021 | SESE |
| K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL | Centervue S.P.A. | Aug 19, 2021 | SESE |
| K192113 | DRSplus | Centervue S.P.A. | Nov 15, 2019 | SESE |
| K180526 | EIDON FA | Centervue S.P.A. | Jul 16, 2018 | SESE |
| K180293 | Retia 2 | Centervue S.P.A. | May 30, 2018 | SESE |
| K153181 | MAIA | Centervue S.P.A. | Jun 8, 2016 | SESE |
| K150320 | COMPASS | Centervue S.P.A. | Jun 30, 2015 | SESE |
| K142897 | P200DTx | Optos Plc. | Jan 16, 2015 | SESE |
| K142047 | EIDON | Centervue S.P.A. | Nov 12, 2014 | SESE |
| K134039 | DAYTONA ICG (P200TICG) | Optos Plc. | Apr 11, 2014 | SESE |
| K112880 | CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE | Freedom Meditech, Inc. | Jan 31, 2013 | SESE |
| K111988 | EASYSCAN MODEL 1.2 | I-Optics BV | Oct 28, 2011 | SESE |
| K111628 | P200T | Optos Plc. | Aug 19, 2011 | SESE |
| K102492 | P200MAAF | Optos Plc. | Sep 30, 2010 | SESE |
| K100644 | OPTOS LIMITED PANORAMIC 200CAF | Optos Plc. | Jul 15, 2010 | SESE |
| K093521 | GDXPRO | Carl Zeiss Meditec, Inc. | Nov 25, 2009 | SESE |
| K082016 | GDX VCC WITH ECC SOFTWARE | Carl Zeiss Meditec, Inc. | Aug 10, 2009 | SESE |
| K091039 | 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
- Ocusciences, Inc. — 1 clearance
- Nidek Co., Ltd. — 1 clearance
