Ophthalmoscope, Laser, Scanning
The Scanning Laser Ophthalmoscope is an ophthalmic diagnostic imaging device that uses a low-power laser beam to scan the fundus (retina and optic nerve) of the eye, producing high-resolution images for the detection and monitoring of conditions such as glaucoma, macular degeneration, and diabetic retinopathy. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 886.1570 (Ophthalmic specialty). This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- MYC
- Device Class
- FDA class 2
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 22 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241931 | OcuMet Beacon (OCUB100) | Apr 22, 2025 | Substantially Equivalent | Ocusciences, Inc. |
| K243504 | MAIA (AHMACME001) | Mar 17, 2025 | Substantially Equivalent | Centervue S.P.A. |
| K213705 | DRSplus | Dec 21, 2021 | Substantially Equivalent | Centervue S.P.A. |
| K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL | Aug 19, 2021 | Substantially Equivalent | Centervue S.P.A. |
| K192113 | DRSplus | Nov 15, 2019 | Substantially Equivalent | Centervue S.P.A. |
| K180526 | EIDON FA | Jul 16, 2018 | Substantially Equivalent | Centervue S.P.A. |
| K180293 | Retia 2 | May 30, 2018 | Substantially Equivalent | Centervue S.P.A. |
| K153181 | MAIA | Jun 08, 2016 | Substantially Equivalent | Centervue S.P.A. |
| K150320 | COMPASS | Jun 30, 2015 | Substantially Equivalent | Centervue S.P.A. |
| K142897 | P200DTx | Jan 16, 2015 | Substantially Equivalent | Optos Plc. |
| K142047 | EIDON | Nov 12, 2014 | Substantially Equivalent | Centervue S.P.A. |
| K134039 | DAYTONA ICG (P200TICG) | Apr 11, 2014 | Substantially Equivalent | Optos Plc. |
| K112880 | CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE | Jan 31, 2013 | Substantially Equivalent | Freedom Meditech, Inc. |
| K111988 | EASYSCAN MODEL 1.2 | Oct 28, 2011 | Substantially Equivalent | I-Optics BV |
| K111628 | P200T | Aug 19, 2011 | Substantially Equivalent | Optos Plc. |
| K102492 | P200MAAF | Sep 30, 2010 | Substantially Equivalent | Optos Plc. |
| K100644 | OPTOS LIMITED PANORAMIC 200CAF | Jul 15, 2010 | Substantially Equivalent | Optos Plc. |
| K093521 | GDXPRO | Nov 25, 2009 | Substantially Equivalent | Carl Zeiss Meditec, Inc. |
| K082016 | GDX VCC WITH ECC SOFTWARE | Aug 10, 2009 | Substantially Equivalent | Carl Zeiss Meditec, Inc. |
| K091039 | KOWA, FM-600, MODEL LSS50 | Aug 07, 2009 | Substantially Equivalent | Kowa Co. , Ltd. |
| K072259 | OPHTHALMOSCOPE F-10 | May 06, 2008 | Substantially Equivalent | Nidek Co., Ltd. |
| K060424 | PANORAMIC, MODEL 200MA | Mar 17, 2006 | Substantially Equivalent | Optos Plc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.