Product code FSS— General, Plastic Surgery

FDA has cleared 20 devices under product code FSS between 1986 and 2009, filed by 17 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20091 clearance
• 20011 clearance
• 19991 clearance
• 19984 clearances
• 19971 clearance
• 19962 clearances
• 19931 clearance
• 19911 clearance
• 19894 clearances
• 19883 clearances
• 19861 clearance

• Cuda Products Co.3 clearances
• Kinetic Biomedical Services, Inc.2 clearances
• Trumpf Medizin Systeme GmbH + Co. KG1 clearance
• Stryker Endoscopy1 clearance
• Perkinelmer Optoelectronics1 clearance
• Medical Illumination International, Inc.1 clearance
• Mdt Biologic Co.1 clearance
• Light Technology Systems1 clearance
• Heraeus Med GmbH1 clearance
• Ferguson Medical1 clearance

• K091246 — ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)Trumpf Medizin Systeme GmbH + Co. KG·2009-09-28
• K003489 — NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8Medical Illumination International, Inc.·2001-02-02
• K984124 — AESCULAP XENON LIGHT SOURCEAesculap, Inc.·1999-02-01
• K981962 — CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCECuda Products Co.·1998-08-18
• K981821 — VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATORAngiolaz, Inc.·1998-07-29
• K981469 — CERMAX300 LIGHTSOURCECuda Products Co.·1998-07-09
• K980044 — XENON 300MXPerkinelmer Optoelectronics·1998-04-03
• K970886 — HANAULUX BLUE 80 HOSPITALHeraeus Med GmbH·1997-04-16
• K961971 — Q-5000Stryker Endoscopy·1996-06-28
• K961074 — LIGHTSOURCE OR ILLUMINATORCuda Products Co.·1996-04-30
• K930711 — TRI*STARLight Technology Systems·1993-07-30
• K910942 — AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHTMdt Biologic Co.·1991-06-11
• K895950 — MODEL FEL5100 FLOOR LIGHTF.W. Lang Co.·1989-10-31
• K893813 — FLOOR STANDING, OPERATING AND EXAMINING LIGHTAstralite Corp.·1989-07-14
• K891758 — KINETIC MODEL 132Kinetic Biomedical Services, Inc.·1989-04-19
• K891759 — KINETIC MODEL 330Kinetic Biomedical Services, Inc.·1989-04-19
• K882333 — FLOOR LIGHTCommercial Products & Engineering Co.·1988-06-23
• K880540 — LIGHT, SURGICAL, FLOOR STANDINGFerguson Medical·1988-02-24
• K880198 — GEMINI SURGICAL LIGHTAmerican Sterilizer Co.·1988-02-10
• K860020 — MINOR SURGERY LIGHT MODEL 2112Adel Medical , Ltd.·1986-01-24