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

Products, Contact Lens Care, Rigid Gas Permeable

21 CFR 886.5918 / Ophthalmic
FDA source (opens on fda.gov)

MRC is the FDA product code for Products, Contact Lens Care, Rigid Gas Permeable, a class II device type, regulated under 21 CFR 886.5918. As of , FDA records hold 33 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
MRC
Device name
Products, Contact Lens Care, Rigid Gas Permeable
Regulation
21 CFR 886.5918
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
33
Ingested recalls
4

Clearances, product code MRC

By decision year
33 clearances under product code MRC with a decision year between 1998 and 2025, 2000 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code MRC by decision year
YearClearances
19982
19991
200010
20011
20023
20032
20041
20051
20101
20132
20172
20183
20191
20202
20251

Applicants with the most clearances

Product code MRC
Applicants holding the most 510(k) clearances under product code MRC
ApplicantClearances
Alcon Laboratories6
Menicon Co. Ltd.6
Bausch & Lomb Incorporated5
Lobob Laboratories, Inc.3
Alcon Universal, Ltd.2
Advanced Medical Optics, Inc.1
Biomatrix, Inc.1
Contamac Ltd.1
Dry Eye Innovations, LLC1
Nof Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order