Cleared Special

K050308 - THERMAL CAUTERY PROBE

K050308 is an FDA 510(k) clearance for THERMAL CAUTERY PROBE, manufactured by Starion Instruments. The device is a Class 2 Ophthalmic device with product code HQR cleared through the Special 510(k) pathway after a 17-day FDA review.

K050308 · Starion Instruments · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
17d
Days
Class 2
Risk

K050308 is an FDA 510(k) clearance for the THERMAL CAUTERY PROBE. Classified as Apparatus, Cautery, Radiofrequency, Ac-powered (product code HQR), Class II - Special Controls.

Submitted by Starion Instruments (Saratoga, US). The FDA issued a Cleared decision on February 25, 2005 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4100 - 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 - K050308

510(k) Number K050308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2005
Decision Date February 25, 2005
Days to Decision 17 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
93d faster than avg
Panel avg: 110d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

HQR Device Classification - Class 2, Special Controls

Product Code HQR Apparatus, Cautery, Radiofrequency, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4100
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 - HQR Apparatus, Cautery, Radiofrequency, Ac-powered

All 10
Devices cleared under the same product code (HQR) and FDA review panel - the closest regulatory comparables to K050308.
DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
K990064 · Ophthalmic Technologies, Inc. · Apr 1999
REFRACTEC MCS-100
K980522 · Refractec, Inc. · Jul 1998
PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
K972749 · C.M. Chance , Ltd. · Mar 1998
STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
K952151 · Storz · Mar 1996
SURGITRON
K955158 · Ellman Intl., Inc. · Feb 1996
GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
K952569 · Gamp & Assoc. · Jan 1996
K050308 · THERMAL CAUTERY PROBE
Download PDF FDA Summary Starion Instruments