Cleared Traditional

K961243 - OCUSYSTEM ART ADVANTAGE

K961243 is an FDA 510(k) clearance for OCUSYSTEM ART ADVANTAGE, manufactured by Surgical Design Corp.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K961243 · Surgical Design Corp. · Ophthalmic device
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Jul 1996
Decision
100d
Days
Class 2
Risk

K961243 is an FDA 510(k) clearance for the OCUSYSTEM ART ADVANTAGE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Surgical Design Corp. (Washington, US). The FDA issued a Cleared decision on July 10, 1996 after a review of 100 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 Surgical Design Corp. devices

FDA 510(k) Submission Details - K961243

510(k) Number K961243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1996
Decision Date July 10, 1996
Days to Decision 100 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
10d faster than avg
Panel avg: 110d · This submission: 100d
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 186
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K961243.
MEGATRON OPHTHALMIC SURGICAL SYSTEM
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CTM DISPOSABLE PAK
K962431 · Circuit Tree Medical, Inc. · Jul 1996
STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
K961310 · Storz Instrument Co. · Jun 1996
SYNERGIST POWER PACK
K960414 · Chiron Vision Corp. · Apr 1996
STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX
K955901 · Storz Instrument Co. · Mar 1996