Cleared Traditional

K024289 - BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION

K024289 is an FDA 510(k) clearance for BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION, manufactured by Bausch & Lomb, Incorporated. The device is a Class 2 Ophthalmic device with product code MRC cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K024289 · Bausch & Lomb, Incorporated · Ophthalmic device
Download Printable Device Report (PDF)
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May 2003
Decision
130d
Days
Class 2
Risk

K024289 is an FDA 510(k) clearance for the BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION. Classified as Products, Contact Lens Care, Rigid Gas Permeable (product code MRC), Class II - Special Controls.

Submitted by Bausch & Lomb, Incorporated (Rochester, US). The FDA issued a Cleared decision on May 2, 2003 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5918 - 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, Incorporated devices

FDA 510(k) Submission Details - K024289

510(k) Number K024289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date May 02, 2003
Days to Decision 130 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
20d slower than avg
Panel avg: 110d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRC Device Classification - Class 2, Special Controls

Product Code MRC Products, Contact Lens Care, Rigid Gas Permeable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5918
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 - MRC Products, Contact Lens Care, Rigid Gas Permeable

All 14
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