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FDA 510(k)

LASER PERIPHERALS HOLMIUM BARE FIBERS

K-Number: K972272 · 1997-07-29

ApplicantLaser Peripherals, LLC
Decision Date1997-07-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER PERIPHERALS HOLMIUM BARE FIBERS is the device name listed in this FDA 510(k) record. The listed applicant is Laser Peripherals, LLC. It received FDA 510(k) clearance on 1997-07-29 under 510(k) number K972272. 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 LASER PERIPHERALS HOLMIUM BARE FIBERS?

LASER PERIPHERALS HOLMIUM BARE FIBERS is a medical device that received FDA 510(k) clearance on 1997-07-29. The listed applicant is Laser Peripherals, LLC. The 510(k) number is K972272.

When did LASER PERIPHERALS HOLMIUM BARE FIBERS receive FDA 510(k) clearance?

LASER PERIPHERALS HOLMIUM BARE FIBERS received FDA 510(k) clearance on 1997-07-29, under 510(k) number K972272.

Who is the listed applicant for LASER PERIPHERALS HOLMIUM BARE FIBERS?

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

What is the FDA product code for LASER PERIPHERALS HOLMIUM BARE FIBERS?

The FDA product code for LASER PERIPHERALS HOLMIUM BARE FIBERS is GEX. This falls under the Gastroenterology category.

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Other records listing Laser Peripherals, LLC 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.

K170366Laser Peripherals, LLC Family of Bare Laser FibersK030959BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100K011207LASER PERIPHERALS REUSABLE HOLMIUM FIBERK992083SCATTERFREE LATERAL EMITTING FIBERK974229LS-905 FIBERCHOICE ADAPTER SYSTEMK961516LASER PERIPHERALS INC. BARE FIBER

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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

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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