Cleared Traditional

K860014 - SYSTEMS PLUS

K860014 is an FDA 510(k) clearance for SYSTEMS PLUS, manufactured by United Surgical Corp.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K860014 · United Surgical Corp. · Ophthalmic device
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Mar 1986
Decision
61d
Days
Class 2
Risk

K860014 is an FDA 510(k) clearance for the SYSTEMS PLUS. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by United Surgical Corp. (Irvine, US). The FDA issued a Cleared decision on March 5, 1986 after a review of 61 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United Surgical Corp. devices

FDA 510(k) Submission Details - K860014

510(k) Number K860014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1986
Decision Date March 05, 1986
Days to Decision 61 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 110d · This submission: 61d
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 93
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K860014.
SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE
K862943 · Site Microsurgical Systems, Inc. · Aug 1986
SERIES TEN THOUSAND MASTER
K861380 · CooperVision, Inc. · Jul 1986
SERIES TEN THOUSAND COMPACT
K861565 · CooperVision, Inc. · Jul 1986
I/A - VFE SYSTEM II
K854868 · Mira, Inc. · Feb 1986
MICRO SURGICAL SYSTEM
K854871 · Mira, Inc. · Feb 1986
STORZ DAISY
K854508 · Storz Instrument Co. · Feb 1986