510(k) K173365

Bausch + Lomb Boston Scleral Lens Case by Bausch & Lomb, Incorporated — Product Code LRX

K173365 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Incorporated for the device "Bausch + Lomb Boston Scleral Lens Case". The FDA issued a decision of Substantially Equivalent on November 17, 2017. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Bausch & Lomb, Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2017
Date Received
October 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Case, Contact Lens
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type