Product Code: FSS FDA class 2 21 CFR 878.4580

Light, Surgical, Floor Standing

General, Plastic Surgery

A floor-standing surgical light is a mobile or fixed-position high-intensity lighting unit used to illuminate the surgical field in operating rooms and procedure areas. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FSS, 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

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Basic Information

Product Code: FSS
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 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K091246	ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)	Sep 28, 2009	Substantially Equivalent	Trumpf Medizin Systeme GmbH + Co. KG
K003489	NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8	Feb 02, 2001	Substantially Equivalent	Medical Illumination International, Inc.
K984124	AESCULAP XENON LIGHT SOURCE	Feb 01, 1999	Substantially Equivalent	Aesculap, Inc.
K981962	CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE	Aug 18, 1998	Substantially Equivalent	Cuda Products Co.
K981821	VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR	Jul 29, 1998	Substantially Equivalent	Angiolaz, Inc.
K981469	CERMAX300 LIGHTSOURCE	Jul 09, 1998	Substantially Equivalent	Cuda Products Co.
K980044	XENON 300MX	Apr 03, 1998	Substantially Equivalent	Perkinelmer Optoelectronics
K970886	HANAULUX BLUE 80 HOSPITAL	Apr 16, 1997	Substantially Equivalent	Heraeus Med GmbH
K961971	Q-5000	Jun 28, 1996	Substantially Equivalent	Stryker Endoscopy
K961074	LIGHTSOURCE OR ILLUMINATOR	Apr 30, 1996	Substantially Equivalent	Cuda Products Co.
K930711	TRI*STAR	Jul 30, 1993	Substantially Equivalent	Light Technology Systems
K910942	AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT	Jun 11, 1991	Substantially Equivalent	Mdt Biologic Co.
K895950	MODEL FEL5100 FLOOR LIGHT	Oct 31, 1989	Substantially Equivalent	F.W. Lang Co.
K893813	FLOOR STANDING, OPERATING AND EXAMINING LIGHT	Jul 14, 1989	Substantially Equivalent	Astralite Corp.
K891759	KINETIC MODEL 330	Apr 19, 1989	Substantially Equivalent	Kinetic Biomedical Services, Inc.
K891758	KINETIC MODEL 132	Apr 19, 1989	Substantially Equivalent	Kinetic Biomedical Services, Inc.
K882333	FLOOR LIGHT	Jun 23, 1988	Substantially Equivalent	Commercial Products & Engineering Co.
K880540	LIGHT, SURGICAL, FLOOR STANDING	Feb 24, 1988	Substantially Equivalent	Ferguson Medical
K880198	GEMINI SURGICAL LIGHT	Feb 10, 1988	Substantially Equivalent	American Sterilizer Co.
K860020	MINOR SURGERY LIGHT MODEL 2112	Jan 24, 1986	Substantially Equivalent	Adel Medical , Ltd.