MYC · Class II · 21 CFR 886.1570

FDA Product Code MYC: Ophthalmoscope, Laser, Scanning

Leading manufacturers include Centervue S.P.A., Optos Plc. and Carl Zeiss Meditec, Inc..

22
Total
22
Cleared
147d
Avg days
2006
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 210d recently vs 140d historically

FDA 510(k) Cleared Ophthalmoscope, Laser, Scanning Devices (Product Code MYC)

22 devices
1–22 of 22
Cleared Apr 22, 2025
OcuMet Beacon (OCUB100)
K241931
Ocusciences, Inc.
Ophthalmic · 295d
Cleared Mar 17, 2025
MAIA (AHMACME001)
K243504
Centervue S.P.A.
Ophthalmic · 125d
Cleared Dec 21, 2021
DRSplus
K213705
Centervue S.P.A.
Ophthalmic · 27d
Cleared Aug 19, 2021
EIDON FA, EIDON, EIDON AF, EIDON UWFL
K211328
Centervue S.P.A.
Ophthalmic · 108d
Cleared Nov 15, 2019
DRSplus
K192113
Centervue S.P.A.
Ophthalmic · 102d
Cleared Jul 16, 2018
EIDON FA
K180526
Centervue S.P.A.
Ophthalmic · 139d
Cleared May 30, 2018
Retia 2
K180293
Centervue S.P.A.
Ophthalmic · 118d
Cleared Jun 08, 2016
MAIA
K153181
Centervue S.P.A.
Ophthalmic · 218d
Cleared Jun 30, 2015
COMPASS
K150320
Centervue S.P.A.
Ophthalmic · 141d
Cleared Jan 16, 2015
P200DTx
K142897
Optos Plc.
Ophthalmic · 105d
Cleared Nov 12, 2014
EIDON
K142047
Centervue S.P.A.
Ophthalmic · 107d
Cleared Apr 11, 2014
DAYTONA ICG (P200TICG)
K134039
Optos Plc.
Ophthalmic · 101d
Cleared Jan 31, 2013
CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE
K112880
Freedom Meditech, Inc.
Ophthalmic · 489d
Cleared Oct 28, 2011
EASYSCAN MODEL 1.2
K111988
I-Optics BV
Ophthalmic · 107d
Cleared Aug 19, 2011
P200T
K111628
Optos Plc.
Ophthalmic · 70d
Cleared Nov 25, 2009
GDXPRO
K093521
Carl Zeiss Meditec, Inc.
Ophthalmic · 12d
Cleared Aug 10, 2009
GDX VCC WITH ECC SOFTWARE
K082016
Carl Zeiss Meditec, Inc.
Ophthalmic · 391d
Cleared Aug 07, 2009
KOWA, FM-600, MODEL LSS50
K091039
Kowa Co. , Ltd.
Ophthalmic · 116d
Cleared May 06, 2008
OPHTHALMOSCOPE F-10
K072259
Nidek Co., Ltd.
Ophthalmic · 266d

About Product Code MYC - Regulatory Context

510(k) Submission Activity

22 total 510(k) submissions under product code MYC since 2006, with 22 receiving FDA clearance (average review time: 147 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MYC Product Code

Recent submissions under MYC have taken an average of 210 days to reach a decision - up from 140 days historically. Manufacturers should account for longer review timelines in current project planning.

MYC devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →