Cleared Traditional

K993039 - VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)

K993039 is an FDA 510(k) clearance for VISCOUS FLUID INJECTOR SYSTEM MODULE (C..., manufactured by Bausch & Lomb, Inc.. The device is a Class 2 Ophthalmic device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K993039

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.

MRH Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MRH Pump, Infusion, Ophthalmic

All 19
Devices cleared under the same product code (MRH) and FDA review panel - the closest regulatory comparables to K993039.
VISCOELASTIC INJECTOR
K132494 · Sight Sciences, Inc. · Oct 2013
ISCIENCE SURGICAL VISCOINJECTOR
K050716 · Iscience Surgical Corporation · Apr 2005
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
K000420 · Retinalabs.Com · May 2000
V.F.I.-VISCOUS FLUID INFUSION TUBING SET
K981907 · Peregrine Surgical , Ltd. · Aug 1998
CPD COMMANDER
K974253 · Scieran Technologies, Inc. · Feb 1998
STORZ MILLENNIUM VISCOUS FLUID SYSTEM
K972664 · Storz Instrument Co. · Oct 1997
K993039 · VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
Download PDF FDA Summary Bausch & Lomb, Inc.