Cleared Traditional

ISOLUX SURGICAL HEADLIGHT

K991572 · Isolux America · General & Plastic Surgery

Jul 1999

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K991572 is an FDA 510(k) clearance for the ISOLUX SURGICAL HEADLIGHT, a Light, Surgical, Fiberoptic (Class II — Special Controls, product code FST), submitted by Isolux America (Naples, US). The FDA issued a Cleared decision on July 8, 1999, 64 days after receiving the submission on May 5, 1999. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number	K991572 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 05, 1999
Decision Date	July 08, 1999
Days to Decision	64 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement