Cleared Traditional

K802381 - LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.

K802381 is an FDA 510(k) clearance for LEWICKY ANTERIOR CHAMBER MAINTEN. SYS., manufactured by Fibra Sonics, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K802381 · Fibra Sonics, Inc. · Ophthalmic device
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Dec 1980
Decision
79d
Days
Class 2
Risk

K802381 is an FDA 510(k) clearance for the LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Fibra Sonics, Inc. (Walker, US). The FDA issued a Cleared decision on December 17, 1980 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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 Fibra Sonics, Inc. devices

FDA 510(k) Submission Details - K802381

510(k) Number K802381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1980
Decision Date December 17, 1980
Days to Decision 79 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 110d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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.