Cleared Special

K070871 - STARION UNIVERSAL POWER SUPPLY

K070871 is an FDA 510(k) clearance for STARION UNIVERSAL POWER SUPPLY, manufactured by Starion Instruments. The device is a Class 2 Ophthalmic device with product code HQO cleared through the Special 510(k) pathway after a 15-day FDA review.

K070871 · Starion Instruments · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
15d
Days
Class 2
Risk

K070871 is an FDA 510(k) clearance for the STARION UNIVERSAL POWER SUPPLY. Classified as Unit, Cautery, Thermal, Ac-powered (product code HQO), Class II - Special Controls.

Submitted by Starion Instruments (Sunnyvale, US). The FDA issued a Cleared decision on April 13, 2007 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4115 - 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 Starion Instruments devices

FDA 510(k) Submission Details - K070871

510(k) Number K070871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2007
Decision Date April 13, 2007
Days to Decision 15 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
95d faster than avg
Panel avg: 110d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

HQO Device Classification - Class 2, Special Controls

Product Code HQO Unit, Cautery, Thermal, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4115
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 - HQO Unit, Cautery, Thermal, Ac-powered

Devices cleared under the same product code (HQO) and FDA review panel - the closest regulatory comparables to K070871.
MENTOR GEMINI HEMOSTATIC ERASER
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K874367 · Spembly Medical , Ltd. · Jan 1988
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K852075 · Valley Forge Scientific Corp. · Aug 1985