Product Code: FTA FDA class 2 21 CFR 878.4580

Light, Surgical, Accessories

General, Plastic Surgery

Surgical light accessories encompass ancillary components and attachments used with surgical lighting systems, such as handles, covers, or mounting adapters, designed to extend or customize the functionality of the lighting unit. They are classified as FDA Class 2 (moderate risk), subject to general and special controls, and require 510(k) premarket notification. The product code is FTA, regulated under 21 CFR 878.4580, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FTA
Device Class: FDA class 2
Regulation Number: 878.4580
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 26 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K150532	Universal Light Handle Cover, Light Handle Cover	Sep 22, 2015	Substantially Equivalent	Key Surgical, Inc.
K142386	Operating Room Light Handle Adapter	Sep 29, 2014	Substantially Equivalent	Litex Manufacturing, Inc.
K133554	SURGICAL LIGHT HANDLE COVER	Apr 08, 2014	Substantially Equivalent	Microtek Medical, Inc. an Ecolab Company
K133413	IDSS SLC	Jan 07, 2014	Substantially Equivalent	Black Diamond Video
K112133	OASYS SURGICAL LIGHT CONTROLLER	Mar 01, 2012	Substantially Equivalent	Oasys Healthcare
K102791	EASYSUITE SURGICAL LIGHT CONTROL (ESLC)	Nov 23, 2010	Substantially Equivalent	Image Stream Medical, Inc.
K081698	MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)	Jul 30, 2008	Substantially Equivalent	Image Stream Medical, Inc.
K053321	LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER	Jan 19, 2006	Substantially Equivalent	Xodus Medical, Inc.
K051505	SCB/STERIS OR-LIGHT INTERFACE BOX	Aug 11, 2005	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K023704	KSEA SCB ACC CONTROL	Jan 30, 2003	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K020640	KSEA SCB MEDIA CONTROL	May 28, 2002	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K020304	DISPOSABLE LIGHT HANDLE AND ADAPTOR	Feb 14, 2002	Substantially Equivalent	Aspen Surgical Products, Inc.
K993089	DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER	Oct 14, 1999	Substantially Equivalent	Deroyal Cardiovascular, Inc.
K954940	MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE	Jan 17, 1996	Substantially Equivalent	Mdt Biologic Co.
K935102	SATURN LIGHT	Jun 27, 1994	Substantially Equivalent	Burton Medical Products Corp.
K915068	PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER	Feb 06, 1992	Substantially Equivalent	American Medical Mfg., Inc.
K901154	MICROTEK'S SURGICAL LAMP HANDLE & COVER	Mar 20, 1990	Substantially Equivalent	Microbio-Medics, Inc.
K894397	WELCON LIGHT HANDLE	Aug 10, 1989	Substantially Equivalent	Welcon, Inc.
K890867	TC SYSTEM-COVER	Mar 14, 1989	Substantially Equivalent	Transmedical Corp.
K890866	TC SYSTEM-HANDLE	Mar 14, 1989	Substantially Equivalent	Transmedical Corp.
K890539	SURE COUNT LIGHT HANDLE COVER	Feb 27, 1989	Substantially Equivalent	Kleen Test Products
K882132	LIGHT, SURGICAL ACCESSORIES	Jun 15, 1988	Substantially Equivalent	Charles Polo & Co., Inc.
K871034	LCA 2000	Apr 10, 1987	Substantially Equivalent	Vistek Corp.
K862010	CHICK SURGICAL LIGHT	Jun 09, 1986	Substantially Equivalent	Professional Medical Products, Inc.
K810292	CAM-WRAP	Mar 04, 1981	Substantially Equivalent	Medline Industries, Inc.
K780162	DIGAPHOT PHOTOTHERAPY METER MODEL PT 145	Mar 27, 1978	Substantially Equivalent	Cavitron Corp.