Cleared Special

K043155 - STARION UNIVERSAL POWER SUPPLY (UPS)

K043155 is an FDA 510(k) clearance for STARION UNIVERSAL POWER SUPPLY (UPS), 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 24-day FDA review.

K043155 · Starion Instruments · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
24d
Days
Class 2
Risk

K043155 is an FDA 510(k) clearance for the STARION UNIVERSAL POWER SUPPLY (UPS). Classified as Unit, Cautery, Thermal, Ac-powered (product code HQO), Class II - Special Controls.

Submitted by Starion Instruments (Saratoga, US). The FDA issued a Cleared decision on December 9, 2004 after a review of 24 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.

FDA 510(k) Submission Details - K043155

510(k) Number K043155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2004
Decision Date December 09, 2004
Days to Decision 24 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 110d · This submission: 24d
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

All 9
Devices cleared under the same product code (HQO) and FDA review panel - the closest regulatory comparables to K043155.
STARION UNIVERSAL POWER SUPPLY
K070871 · Starion Instruments · Apr 2007
THERMAL CAUTERY UNIT, MODEL 150
K002341 · Geiger Medical Technologies, Inc. · Oct 2000
AC POWERED THERMAL CAUTERY UNIT
K000893 · Starion Instruments · Jun 2000
MENTOR GEMINI HEMOSTATIC ERASER
K971538 · Mentor Ophthalmics, Inc. · Jul 1997
D.O.R.C. MICRODIATHERMY SYSTEM
K962135 · Dutch Ophthalmic USA, Inc. · Aug 1996
BIPOLAR ELECTROSURGICAL PENCIL
K943031 · Boston Surgical Products, Inc. · Sep 1994
K043155 · STARION UNIVERSAL POWER SUPPLY (UPS)
Download PDF FDA Summary Starion Instruments