Cleared Special

K131787 - CRYOMATIC MKII CONSOLE

K131787 is an FDA 510(k) clearance for CRYOMATIC MKII CONSOLE, manufactured by Keeler, Ltd.. The device is a Class 2 Ophthalmic device with product code HRN cleared through the Special 510(k) pathway after a 188-day FDA review.

K131787 · Keeler, Ltd. · Ophthalmic device
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Dec 2013
Decision
188d
Days
Class 2
Risk

K131787 is an FDA 510(k) clearance for the CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES. Classified as Unit, Cryophthalmic, Ac-powered (product code HRN), Class II - Special Controls.

Submitted by Keeler, Ltd. (Broomall, US). The FDA issued a Cleared decision on December 23, 2013 after a review of 188 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4170 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Keeler, Ltd. devices

FDA 510(k) Submission Details - K131787

510(k) Number K131787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2013
Decision Date December 23, 2013
Days to Decision 188 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 110d · This submission: 188d
Pathway characteristics
Modification to existing cleared device.

HRN Device Classification - Class 2, Special Controls

Product Code HRN Unit, Cryophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4170
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 - HRN Unit, Cryophthalmic, Ac-powered

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