Cleared Traditional

K943379 - PHACO TIPS FOR PHACO FRAGMENTATION MACHINES

K943379 is an FDA 510(k) clearance for PHACO TIPS FOR PHACO FRAGMENTATION MACHINES, manufactured by Oasis Medical, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K943379 · Oasis Medical, Inc. · Ophthalmic device
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Oct 1994
Decision
90d
Days
Class 2
Risk

K943379 is an FDA 510(k) clearance for the PHACO TIPS FOR PHACO FRAGMENTATION MACHINES. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on October 11, 1994 after a review of 90 days - within the typical 510(k) review window.

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: 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 Oasis Medical, Inc. devices

FDA 510(k) Submission Details - K943379

510(k) Number K943379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1994
Decision Date October 11, 1994
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
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.

Regulatory Peers - HQC Unit, Phacofragmentation

All 122
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K943379.
STORZ PHACOEMULSIFICATION NEEDLES
K946176 · Storz Instrument Co. · Feb 1995
CASSETTE SYSTEM FOR STORZ
K942945 · Surgin Surgical Instrumentation, Inc. · Dec 1994
STORZ PHACO AND FRAG HANDPIECES
K935926 · Storz Instrument Co. · Nov 1994
HIGH PERFORMANCE TIPS
K943102 · Surgin Surgical Instrumentation, Inc. · Jul 1994
PHACO KIT
K942515 · Surgin Surgical Instrumentation, Inc. · Jul 1994
10-0 CASSETTE
K942516 · Surgin Surgical Instrumentation, Inc. · Jul 1994