Cleared Traditional

K991852 - OCUSYSTEM ART ADVANTAGE, MODEL 995

K991852 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 36-day FDA review.

K991852 · Surgical Design Corp. · Ophthalmic device
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Jul 1999
Decision
36d
Days
Class 2
Risk

K991852 is an FDA 510(k) clearance for the OCUSYSTEM ART ADVANTAGE, MODEL 995. 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 7, 1999 after a review of 36 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.

FDA 510(k) Submission Details - K991852

510(k) Number K991852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1999
Decision Date July 07, 1999
Days to Decision 36 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
74d faster than avg
Panel avg: 110d · This submission: 36d
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 313
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K991852.
PHACOFRAGMENTATION SYSTEM MEGATRON
K002031 · Asclepion-Meditec AG · Dec 2000
A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
K002986 · A.R.C. Laser AG · Nov 2000
IRIS RETRACTING PHACOEMULSIFICATION SLEEVE
K002812 · Michael Reynard, M.D. · Nov 2000
FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
K984143 · Fibra Sonics, Inc. · Feb 1999
THE WAVE DIGITAL PHACO SYSTEM
K981989 · Circuit Tree · Aug 1998
TURBOSONICS LIMITED REUSE ULTRASONIC TIP
K981103 · Alcon Laboratories · Jun 1998
K991852 · OCUSYSTEM ART ADVANTAGE, MODEL 995
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