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FDA 510(k)

NUVOLASE 532 MEDICAL LASER SYSTEM

K-Number: K010046 · 2001-04-05

ApplicantAmerican Laser Corp.
Decision Date2001-04-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NUVOLASE 532 MEDICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Laser Corp.. It received FDA 510(k) clearance on 2001-04-05 under 510(k) number K010046. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUVOLASE 532 MEDICAL LASER SYSTEM?

NUVOLASE 532 MEDICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2001-04-05. The listed applicant is American Laser Corp.. The 510(k) number is K010046.

When did NUVOLASE 532 MEDICAL LASER SYSTEM receive FDA 510(k) clearance?

NUVOLASE 532 MEDICAL LASER SYSTEM received FDA 510(k) clearance on 2001-04-05, under 510(k) number K010046.

Who is the listed applicant for NUVOLASE 532 MEDICAL LASER SYSTEM?

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

What is the FDA product code for NUVOLASE 532 MEDICAL LASER SYSTEM?

The FDA product code for NUVOLASE 532 MEDICAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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.

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Other records listing American Laser 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.

K990665BQ/BM INTEGRATED LASER DELIVERY SYSTEMK990725NUVOLASE 532 LASER SYSTEMK827819LASER PHOTOCOAGULATORK813429LASER PHOTOCOAGULATOR ARGON MED. LASER

Related Devices (Code: GEX)

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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.

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