Cleared Traditional

K972522 - ML-DISPOSABLE PAK

K972522 is an FDA 510(k) clearance for ML-DISPOSABLE PAK, manufactured by Med-Logics, Inc.. The device is a Class 2 Ophthalmic device with product code MSR cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K972522 · Med-Logics, Inc. · Ophthalmic device
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Sep 1997
Decision
85d
Days
Class 2
Risk

K972522 is an FDA 510(k) clearance for the ML-DISPOSABLE PAK. Classified as Tubing, Replacement, Phacofragmentation Unit (product code MSR), Class II - Special Controls.

Submitted by Med-Logics, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on September 30, 1997 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Med-Logics, Inc. devices

FDA 510(k) Submission Details - K972522

510(k) Number K972522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1997
Decision Date September 30, 1997
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSR Device Classification - Class 2, Special Controls

Product Code MSR Tubing, Replacement, Phacofragmentation Unit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
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.