510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K993039Substantially Equivalent

Viscous Fluid Injector System Module (Cx5700)

Bausch & Lomb Incorporated, St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993039 is the FDA 510(k) clearance record for VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700), a class II device, cleared for Bausch & Lomb, Inc. on under FDA product code MRH (Pump, Infusion, Ophthalmic). FDA records list 131 510(k) clearances for Bausch & Lomb Incorporated, from to . As of , FDA records show no recalls naming K993039.

Clearance record

Decision date
Received
(119 days to decision)
Product code
MRH Pump, Infusion, Ophthalmic
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Bausch & Lomb, Inc. 3365 Tree Ct. Industrial Blvd., St. Louis MO
510(k) summary
Summary
Third party review
No

Clearances, product code MRH

Trailing 12 months
1 clearance under product code MRH in the twelve months to November 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MRH, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260