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FDA 510(k)

LASER 20

K-Number: K011021 · 2001-10-09

ApplicantYa-Man, Ltd.
Decision Date2001-10-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER 20 is the device name listed in this FDA 510(k) record. The listed applicant is Ya-Man, Ltd.. It received FDA 510(k) clearance on 2001-10-09 under 510(k) number K011021. 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 20?

LASER 20 is a medical device that received FDA 510(k) clearance on 2001-10-09. The listed applicant is Ya-Man, Ltd.. The 510(k) number is K011021.

When did LASER 20 receive FDA 510(k) clearance?

LASER 20 received FDA 510(k) clearance on 2001-10-09, under 510(k) number K011021.

Who is the listed applicant for LASER 20?

The FDA 510(k) record lists Ya-Man, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASER 20?

The FDA product code for LASER 20 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 Ya-Man, Ltd. 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.

K250618Medi Lift Essential Eye MaskK244048Medi Lift MaskK220198Medi Lift PLUSK112016L-SER KO LAMPK032944YA-MAN LASER 21

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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