Saturn Light

FDA 510(k) K935102 · Burton Medical Products Corp.

Substantially Equivalent

510(k) numberK935102

Submission

Device name
Saturn Light
Applicant
Burton Medical Products Corp.
Van Nuys, CA, US
Received
October 22, 1993
Decision date
June 27, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FTA – Light, Surgical, Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

Other 510(k)s with product code FTA

510(k)DeviceApplicantDecision
K150532Universal Light Handle Cover, Light Handle CoverFTA · Traditional Key Surgical, Inc.09/22/2015SE
K142386Operating Room Light Handle AdapterFTA · Traditional Litex Manufacturing, Inc.09/29/2014SE
K133554Surgical Light Handle CoverFTA · Special Microtek Medical, Inc. an Ecolab Company04/08/2014SE
K133413Idss SLCFTA · Traditional Black Diamond Video01/07/2014SE
K112133Oasys Surgical Light ControllerFTA · Traditional Oasys Healthcare03/01/2012SE
K102791Easysuite Surgical Light Control (Eslc)FTA · Special Image Stream Medical, Inc.11/23/2010SE
K081698Mainstream or Surgical Light Control (MSLC)FTA · Abbreviated Image Stream Medical, Inc.07/30/2008SE
K053321Light Guard Light Handle and Light Handle CoverFTA · Traditional Xodus Medical, Inc.01/19/2006SE
K051505Scb/Steris Or-Light Interface BoxFTA · Traditional KARL STORZ Endoscopy-America, Inc.08/11/2005SE
K023704Ksea SCB Acc ControlFTA · Traditional KARL STORZ Endoscopy-America, Inc.01/30/2003SE

More from KARL STORZ Endoscopy-America, Inc.

510(k)DeviceDecision
K101537Aim 200, Major Surgical LightFSY · Traditional 09/30/2010SE
K042395Outpatient III Minor Surgery LightFSY · Traditional 12/01/2004SE
K000639Visionary 2000FSY · Traditional 05/25/2000SE
K963682Genie' Single Ceiling and Double CeilingFSY · Traditional 11/13/1996SE
K961843GenieFSY · Traditional 08/22/1996SE
K942553GenesisFTD · Traditional 06/23/1994SE
K936088Wave Fluorescent MagnifierKZF · Traditional 04/26/1994SE
K931645Halux TasklightKZF · Traditional 08/20/1993SE
K901706Light, Head, ExaminationKZF · Traditional 07/19/1990SE
K893808Model 0450000, Opal Medical Exam LightKZF · Traditional 08/15/1989SE

Questions and answers

When was Saturn Light cleared by the FDA?

Saturn Light (K935102) received a 510(k) decision of Substantially Equivalent on June 27, 1994, 248 days after the submission was received.

What is the product code of K935102?

The FDA product code is FTA – Light, Surgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4580.