Cleared Abbreviated

K081698 - MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
(FDA 510(k) Clearance)

K081698 · Image Stream Medical, Inc. · General & Plastic Surgery

Jul 2008

Decision

43d

Days

Class 2

Risk

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

Submitted by Image Stream Medical, Inc. (Winchester, US). The FDA issued a Cleared decision on July 30, 2008, 43 days after receiving the submission on June 17, 2008.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number	K081698 FDA.gov
FDA Decision	Cleared 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