Cleared Traditional

K861060 - SITE PHACO DISPOSABLE CASSETTE

K861060 is an FDA 510(k) clearance for SITE PHACO DISPOSABLE CASSETTE, manufactured by Site Microsurgical Systems, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K861060 · Site Microsurgical Systems, Inc. · Ophthalmic device
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May 1986
Decision
47d
Days
Class 2
Risk

K861060 is an FDA 510(k) clearance for the SITE PHACO DISPOSABLE CASSETTE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on May 6, 1986 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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.

FDA 510(k) Submission Details - K861060

510(k) Number K861060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1986
Decision Date May 06, 1986
Days to Decision 47 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
63d faster than avg
Panel avg: 110d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 316
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K861060.
KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.
K860956 · Medical Corp. of America · Jun 1986
DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.
K860957 · Medical Corp. of America · Jun 1986
SITE DISPOSABLE CASSETTE
K860989 · Microsurgical Systems, Inc. · May 1986
AM-100 I/A AMPAC
K860770 · Dravon Medical, Inc. · Apr 1986
PHACO PACKS, 1A PACKS & PACK COMPONENTS
K854116 · Medical Corp. of America · Dec 1985
ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS
K854225 · Advanced Medical Technology, Inc. · Dec 1985
K861060 · SITE PHACO DISPOSABLE CASSETTE
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