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510(k) K930711

TRI*STAR by Light Technology Systems — Product Code FSS

K930711 is an FDA 510(k) premarket notification submitted by Light Technology Systems for the device "TRI*STAR". The FDA issued a decision of Substantially Equivalent on July 30, 1993. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1993
Date Received
February 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Floor Standing
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances for product code FSS

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  • K003489 — NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT G (February 2, 2001)
  • K984124 — AESCULAP XENON LIGHT SOURCE (February 1, 1999)
  • K981962 — CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE (August 18, 1998)
  • K981821 — VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR (July 29, 1998)
  • K981469 — CERMAX300 LIGHTSOURCE (July 9, 1998)
  • K980044 — XENON 300MX (April 3, 1998)
  • K970886 — HANAULUX BLUE 80 HOSPITAL (April 16, 1997)
  • K961971 — Q-5000 (June 28, 1996)
  • K961074 — LIGHTSOURCE OR ILLUMINATOR (April 30, 1996)

FDA data resources