Cleared Traditional

K851936 - STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT

K851936 is an FDA 510(k) clearance for STAAXL-3 SMALL INCISION SYSTEM TM, manufactured by Staar Surgical Co.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K851936

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
Combination Product No
PCCP Authorized No
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.

HQE Device Classification - Class 2, Special Controls

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 92
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K851936.
STORZ IAS DISPOSABLE PACK
K853430 · Storz Instrument Co. · Dec 1985
VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100
K853961 · Visitec Co. · Dec 1985
MAID MENTOR ASPIRATION/IRRIGATION DEVRO
K853382 · Mentor O & O, Inc. · Oct 1985
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001
K852271 · CooperVision, Inc. · Aug 1985
VISITEC 2 MICRON FLUID FILTER
K853135 · Visitec Co. · Aug 1985
COMBINED MVS SYSTEMS
K851610 · Medical Instrument Development Laboratories, Inc. · Jul 1985