FDA 510(k)

TRI*STAR

K-Number: K930711 · 1993-07-30

Decision Date1993-07-30

Product CodeFSS

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TRI*STAR is the device name listed in this FDA 510(k) record. The listed applicant is Light Technology Systems. It received FDA 510(k) clearance on 1993-07-30 under 510(k) number K930711. The device is classified under product code FSS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI*STAR?

TRI*STAR is a medical device that received FDA 510(k) clearance on 1993-07-30. The listed applicant is Light Technology Systems. The 510(k) number is K930711.

When did TRI*STAR receive FDA 510(k) clearance?

TRI*STAR received FDA 510(k) clearance on 1993-07-30, under 510(k) number K930711.

Who is the listed applicant for TRI*STAR?

The FDA 510(k) record lists Light Technology Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRI*STAR?

The FDA product code for TRI*STAR is FSS.

Related Devices (Code: FSS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K091246ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)Trumpf Medizin Systeme GmbH + Co. KG K003489NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8Medical Illumination International, Inc.K984124AESCULAP XENON LIGHT SOURCEAesculap, Inc.K981962CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCECuda Products Co.K981821VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATORAngiolaz, Inc.K981469CERMAX300 LIGHTSOURCECuda Products Co.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.