Cleared Special

K102791 - EASYSUITE SURGICAL LIGHT CONTROL (ESLC)

K102791 is an FDA 510(k) clearance for EASYSUITE SURGICAL LIGHT CONTROL (ESLC), manufactured by Image Stream Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTA cleared through the Special 510(k) pathway after a 57-day FDA review.

K102791 · Image Stream Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
57d
Days
Class 2
Risk

K102791 is an FDA 510(k) clearance for the EASYSUITE SURGICAL LIGHT CONTROL (ESLC). Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by Image Stream Medical, Inc. (Littleton, US). The FDA issued a Cleared decision on November 23, 2010 after a review of 57 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. 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 - K102791

510(k) Number K102791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2010
Decision Date November 23, 2010
Days to Decision 57 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

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

All 25
Devices cleared under the same product code (FTA) and FDA review panel - the closest regulatory comparables to K102791.
SURGICAL LIGHT HANDLE COVER
K133554 · Microtek Medical, Inc. an Ecolab Company · Apr 2014
IDSS SLC
K133413 · Black Diamond Video · Jan 2014
OASYS SURGICAL LIGHT CONTROLLER
K112133 · Oasys Healthcare · Mar 2012
MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
K081698 · Image Stream Medical, Inc. · Jul 2008
LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER
K053321 · Xodus Medical, Inc. · Jan 2006
SCB/STERIS OR-LIGHT INTERFACE BOX
K051505 · KARL STORZ Endoscopy-America, Inc. · Aug 2005
K102791 · EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
Download PDF FDA Summary Image Stream Medical,…