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FDA 510(k)

LUXTEC ACO SERIES 4000 LIGHT SOURCE

K-Number: K890716 · 1989-04-26

ApplicantLuxtec Corp.
Decision Date1989-04-26
Product CodeFCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LUXTEC ACO SERIES 4000 LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Luxtec Corp.. It received FDA 510(k) clearance on 1989-04-26 under 510(k) number K890716. The device is classified under product code FCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUXTEC ACO SERIES 4000 LIGHT SOURCE?

LUXTEC ACO SERIES 4000 LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 1989-04-26. The listed applicant is Luxtec Corp.. The 510(k) number is K890716.

When did LUXTEC ACO SERIES 4000 LIGHT SOURCE receive FDA 510(k) clearance?

LUXTEC ACO SERIES 4000 LIGHT SOURCE received FDA 510(k) clearance on 1989-04-26, under 510(k) number K890716.

Who is the listed applicant for LUXTEC ACO SERIES 4000 LIGHT SOURCE?

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

What is the FDA product code for LUXTEC ACO SERIES 4000 LIGHT SOURCE?

The FDA product code for LUXTEC ACO SERIES 4000 LIGHT SOURCE is FCW.

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Other records listing Luxtec Corp. as applicant

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.

K973193LUXSCOPEK970642TENOSCOPEK970562TENOSNAREK950960REDDY ILLUMINATORK895248IMS5000 ILLUMINATED LOUPESK864387LUXTEC FIBEROPTIC CABLES

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Related Devices (Code: FCW)

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Official Source

View on FDA Database →

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

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