Cleared Traditional

K854871 - MICRO SURGICAL SYSTEM

K854871 is an FDA 510(k) clearance for MICRO SURGICAL SYSTEM, manufactured by Mira, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K854871 · Mira, Inc. · Ophthalmic device
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Feb 1986
Decision
65d
Days
Class 2
Risk

K854871 is an FDA 510(k) clearance for the MICRO SURGICAL SYSTEM. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on February 7, 1986 after a review of 65 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 Mira, Inc. devices

FDA 510(k) Submission Details - K854871

510(k) Number K854871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1985
Decision Date February 07, 1986
Days to Decision 65 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
45d faster than avg
Panel avg: 110d · This submission: 65d
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 72
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K854871.
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
STORZ DAISY
K854508 · Storz Instrument Co. · Feb 1986
STORZ IAS DISPOSABLE PACK
K853430 · Storz Instrument Co. · Dec 1985
VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100
K853961 · Visitec Co. · Dec 1985