Cleared Abbreviated

K081698 - MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)

K081698 is an FDA 510(k) clearance for MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC), manufactured by Image Stream Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTA cleared through the Abbreviated 510(k) pathway after a 43-day FDA review.

K081698 · Image Stream Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
43d
Days
Class 2
Risk

K081698 is an FDA 510(k) clearance for the MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC). Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by Image Stream Medical, Inc. (Winchester, US). The FDA issued a Cleared decision on July 30, 2008 after a review of 43 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Image Stream Medical, Inc. devices

FDA 510(k) Submission Details - K081698

510(k) Number K081698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date July 30, 2008
Days to Decision 43 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Standards-based clearance path.

FTA Device Classification - Class 2, Special Controls

Product Code FTA Light, Surgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTA Light, Surgical, Accessories

Devices cleared under the same product code (FTA) and FDA review panel - the closest regulatory comparables to K081698.
SCB/STERIS OR-LIGHT INTERFACE BOX
K051505 · KARL STORZ Endoscopy-America, Inc. · Aug 2005
KSEA SCB ACC CONTROL
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KSEA SCB MEDIA CONTROL
K020640 · KARL STORZ Endoscopy-America, Inc. · May 2002
SURE COUNT LIGHT HANDLE COVER
K890539 · Kleen Test Products · Feb 1989
CAM-WRAP
K810292 · Medline Industries, Inc. · Mar 1981
DIGAPHOT PHOTOTHERAPY METER MODEL PT 145
K780162 · Cavitron Corp. · Mar 1978