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510(k) K930711

Device
TRI*STAR
Applicant
LIGHT TECHNOLOGY SYSTEMS
510(k) number
K930711
Product code
FSS  
Decision
Substantially Equivalent (SESE)
Decision date
1993-07-30
Date received
1993-02-11
Regulation
878.4580
Classification name
Light, Surgical, Floor Standing
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
HOWARD A WANIGA
Address
16760 Stagg St., #211 Van Nuys CA US 91406 91406

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FSS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K091246ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)Trumpf Medizin Systeme GmbH + Co. KG2009-09-28
K003489NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8Medical Illumination International, Inc.2001-02-02
K984124AESCULAP XENON LIGHT SOURCEAesculap, Inc.1999-02-01
K981962CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCECuda Products Co.1998-08-18
K981821VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATORAngiolaz, Inc.1998-07-29
K981469CERMAX300 LIGHTSOURCECuda Products Co.1998-07-09
K980044XENON 300MXPerkinelmer Optoelectronics1998-04-03
K970886HANAULUX BLUE 80 HOSPITALHeraeus Med GmbH1997-04-16
K961971Q-5000Stryker Endoscopy1996-06-28
K961074LIGHTSOURCE OR ILLUMINATORCuda Products Co.1996-04-30
K910942AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHTMdt Biologic Co.1991-06-11
K895950MODEL FEL5100 FLOOR LIGHTF.W. Lang Co.1989-10-31
K893813FLOOR STANDING, OPERATING AND EXAMINING LIGHTAstralite Corp.1989-07-14
K891758KINETIC MODEL 132Kinetic Biomedical Services, Inc.1989-04-19
K891759KINETIC MODEL 330Kinetic Biomedical Services, Inc.1989-04-19

Legacy Summary#

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FDA Review#

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