Cleared Traditional

K861380 - SERIES TEN THOUSAND MASTER

K861380 is an FDA 510(k) clearance for SERIES TEN THOUSAND MASTER, manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K861380 · CooperVision, Inc. · Ophthalmic device
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Jul 1986
Decision
88d
Days
Class 2
Risk

K861380 is an FDA 510(k) clearance for the SERIES TEN THOUSAND MASTER. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by CooperVision, Inc. (Irvine, US). The FDA issued a Cleared decision on July 11, 1986 after a review of 88 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 CooperVision, Inc. devices

FDA 510(k) Submission Details - K861380

510(k) Number K861380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1986
Decision Date July 11, 1986
Days to Decision 88 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
22d faster than avg
Panel avg: 110d · This submission: 88d
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 K861380.
SITE PERISTALTIC MODULE SYSTEM
K871375 · Site Microsurgical Systems, Inc. · May 1987
ASPIRATION REVERSAL CONTROL (ARC) MODULE
K870068 · Optical Micro Systems, Inc. · Feb 1987
SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE
K862943 · Site Microsurgical Systems, Inc. · Aug 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