510(k) K173136

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses by Menicon Co, Ltd. — Product Code MRC

K173136 is an FDA 510(k) premarket notification submitted by Menicon Co, Ltd. for the device "Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses". The FDA issued a decision of Substantially Equivalent on November 16, 2017. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Menicon Co, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2017
Date Received
September 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Device Class
Class II
Regulation Number
886.5918
Review Panel
OP
Submission Type