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

Lens, Contact (Orthokeratology)

21 CFR 886.5916 / Ophthalmic
FDA source (opens on fda.gov)

MUW is the FDA product code for Lens, Contact (Orthokeratology), a class II device type, regulated under 21 CFR 886.5916. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MUW
Device name
Lens, Contact (Orthokeratology)
Regulation
21 CFR 886.5916
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
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code MUW

By decision year
6 clearances under product code MUW with a decision year between 1998 and 2019, 2001 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MUW by decision year
YearClearances
19981
20001
20012
20161
20191

Applicants with the most clearances

Product code MUW
Applicants holding the most 510(k) clearances under product code MUW
ApplicantClearances
Paragon Vision Sciences, Inc.2
Airperm, Inc.1
C&E GP Specialist, Inc.1
Contamac Ltd.1
Polymer Technology Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order