Cleared Special

MELIDE FIBEROPTIC LIGHT

K051786 · Designs For Vision, Inc. · General & Plastic Surgery

Aug 2005

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K051786 is an FDA 510(k) clearance for the MELIDE FIBEROPTIC LIGHT, a Light, Surgical, Fiberoptic (Class II — Special Controls, product code FST), submitted by Designs For Vision, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 15, 2005, 45 days after receiving the submission on July 1, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number	K051786 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2005
Decision Date	August 15, 2005
Days to Decision	45 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF