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FDA 510(k)

LUXTEC LIGHT SOURCES

K-Number: K864385 · 1987-01-13

ApplicantLuxtec Corp.
Decision Date1987-01-13
Product CodeFCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LUXTEC LIGHT SOURCES is the device name listed in this FDA 510(k) record. The listed applicant is Luxtec Corp.. It received FDA 510(k) clearance on 1987-01-13 under 510(k) number K864385. 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 LIGHT SOURCES?

LUXTEC LIGHT SOURCES is a medical device that received FDA 510(k) clearance on 1987-01-13. The listed applicant is Luxtec Corp.. The 510(k) number is K864385.

When did LUXTEC LIGHT SOURCES receive FDA 510(k) clearance?

LUXTEC LIGHT SOURCES received FDA 510(k) clearance on 1987-01-13, under 510(k) number K864385.

Who is the listed applicant for LUXTEC LIGHT SOURCES?

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 LIGHT SOURCES?

The FDA product code for LUXTEC LIGHT SOURCES 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 LOUPESK890716LUXTEC ACO SERIES 4000 LIGHT SOURCE

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Related Devices (Code: FCW)

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.

K123956POWER LED 175KARL STORZ Endoscopy-America, Inc.K123359OVS1 VIDEO SYSTEMOlive Medical Corp.K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2Richard Wolf Medical Instruments Corp.K093792LED LIGHT SOURCESunoptic Technologies, LLCK091968KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020CKARL STORZ Endoscopy-America, Inc.K082813STRYKER LED LIGHTSOURCEStryker Corp.

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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