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FDA 510(k)

ISC-1000 PENTAX CONFOCAL LASER SYSTEM

K-Number: K042740 · 2004-10-19

ApplicantPentax Medical Company
Decision Date2004-10-19
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ISC-1000 PENTAX CONFOCAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical Company. It received FDA 510(k) clearance on 2004-10-19 under 510(k) number K042740. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISC-1000 PENTAX CONFOCAL LASER SYSTEM?

ISC-1000 PENTAX CONFOCAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-19. The listed applicant is Pentax Medical Company. The 510(k) number is K042740.

When did ISC-1000 PENTAX CONFOCAL LASER SYSTEM receive FDA 510(k) clearance?

ISC-1000 PENTAX CONFOCAL LASER SYSTEM received FDA 510(k) clearance on 2004-10-19, under 510(k) number K042740.

Who is the listed applicant for ISC-1000 PENTAX CONFOCAL LASER SYSTEM?

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

What is the FDA product code for ISC-1000 PENTAX CONFOCAL LASER SYSTEM?

The FDA product code for ISC-1000 PENTAX CONFOCAL LASER SYSTEM is GCJ.

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Other records listing Pentax Medical Company 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.

K093037PENTEX EC-3890LIK092710PENTAX ED-3490TK, VIDEO DUODENOSCOPEK090196EG-3670URKK090197EG-3870UTKK081518ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UKK061068EG-3670URK

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Related Devices (Code: GCJ)

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K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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