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FDA 510(k)

NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY

K-Number: K972561 · 1997-10-06

ApplicantAmerican Laser Medical
Decision Date1997-10-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is American Laser Medical. It received FDA 510(k) clearance on 1997-10-06 under 510(k) number K972561. 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 660 LASER SYSTEM FOR OPHTHALMOLOGY?

NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY is a medical device that received FDA 510(k) clearance on 1997-10-06. The listed applicant is American Laser Medical. The 510(k) number is K972561.

When did NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY receive FDA 510(k) clearance?

NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY received FDA 510(k) clearance on 1997-10-06, under 510(k) number K972561.

Who is the listed applicant for NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY?

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

What is the FDA product code for NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY?

The FDA product code for NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY is GEX. This falls under the Gastroenterology category.

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Other records listing American Laser Medical 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.

K990780NUVOLASE 532 CUTANEOUS LASER SYSTEMK972765NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASERK970667NUVO-LASE 660 LASER SYSTEMK963389FLEX-LASE 600 SERIES ION LASER SYSTEM

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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