Cleared Traditional

K993039 - VISCOUS FLUID INJECTOR SYSTEM MODULE (C...

K993039 is the FDA 510(k) clearance for VISCOUS FLUID INJECTOR SYSTEM MODULE (C... by Bausch & Lomb, Inc.. It is a Class 2 Ophthalmic device (product code MRH) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K993039 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
119d
Days
Class 2
Risk

K993039 is an FDA 510(k) clearance for the VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700). Classified as Pump, Infusion, Ophthalmic (product code MRH), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 7, 2000 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 880.5725 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Bausch & Lomb, Inc. devices

Submission Details

510(k) Number K993039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1999
Decision Date January 07, 2000
Days to Decision 119 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 110d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRH Pump, Infusion, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.