510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MYCClass II

Ophthalmoscope, Laser, Scanning

21 CFR 886.1570 / Ophthalmic
FDA source (opens on fda.gov)

MYC is the FDA product code for Ophthalmoscope, Laser, Scanning, a class II device type, regulated under 21 CFR 886.1570. As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MYC
Device name
Ophthalmoscope, Laser, Scanning
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
23
Ingested recalls
0

Clearances, product code MYC

By decision year
23 clearances under product code MYC with a decision year between 2006 and 2026, 2009 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MYC by decision year
YearClearances
20061
20081
20093
20102
20112
20131
20142
20152
20161
20182
20191
20212
20252
20261

Applicants with the most clearances

Product code MYC
Applicants holding the most 510(k) clearances under product code MYC
ApplicantClearances
Centervue9
Optos PLC.5
Carl Zeiss Meditec Inc2
Freedom Meditech, Inc.1
I-Optics BV1
Kowa Co., Ltd.1
Kowa Company, Ltd. Chofu Factory1
Nidek Co., Ltd.1
Ocusciences, Inc.1
Optos PLC.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order