Cleared Special

K081565 - INTEGRE PRO

K081565 is an FDA 510(k) clearance for INTEGRE PRO, manufactured by Ellex Medical Pty, Ltd.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Special 510(k) pathway after a 28-day FDA review.

K081565 · Ellex Medical Pty, Ltd. · Ophthalmic device
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Jul 2008
Decision
28d
Days
Class 2
Risk

K081565 is an FDA 510(k) clearance for the INTEGRE PRO, MODEL L2RY. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Ellex Medical Pty, Ltd. (Adelaide, South Australia, AU). The FDA issued a Cleared decision on July 2, 2008 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ellex Medical Pty, Ltd. devices

FDA 510(k) Submission Details - K081565

510(k) Number K081565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2008
Decision Date July 02, 2008
Days to Decision 28 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
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

HQF Device Classification - Class 2, Special Controls

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
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.

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All 85
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