Cleared Traditional

K851936 - STAAXL-3 SMALL INCISION SYSTEM TM

K851936 is the FDA 510(k) clearance for STAAXL-3 SMALL INCISION SYSTEM TM by Staar Surgical Co.. It is a Class 2 Ophthalmic device (product code HQE) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K851936 · Staar Surgical Co. · Ophthalmic device
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Aug 1985
Decision
106d
Days
Class 2
Risk

K851936 is an FDA 510(k) clearance for the STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on August 20, 1985 after a review of 106 days - within the typical 510(k) review window.

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: 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 Staar Surgical Co. devices

Submission Details

510(k) Number K851936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1985
Decision Date August 20, 1985
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 110d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered
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.

Regulatory Peers - HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 37
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K851936.
STORZ DAISY
K854508 · Storz Instrument Co. · Feb 1986
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K853430 · Storz Instrument Co. · Dec 1985
VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100
K853961 · Visitec Co. · Dec 1985
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001
K852271 · CooperVision, Inc. · Aug 1985
VISITEC 2 MICRON FLUID FILTER
K853135 · Visitec Co. · Aug 1985
DISPOSABLE OCUTOME PROBE
K833371 · CooperVision, Inc. · Jan 1984