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FDA 510(k)

EDGE CO2 LASER SYSTEM

K-Number: K100590 · 2010-11-10

ApplicantJm System Co., Ltd.
Decision Date2010-11-10
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EDGE CO2 LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Jm System Co., Ltd.. It received FDA 510(k) clearance on 2010-11-10 under 510(k) number K100590. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDGE CO2 LASER SYSTEM?

EDGE CO2 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-10. The listed applicant is Jm System Co., Ltd.. The 510(k) number is K100590.

When did EDGE CO2 LASER SYSTEM receive FDA 510(k) clearance?

EDGE CO2 LASER SYSTEM received FDA 510(k) clearance on 2010-11-10, under 510(k) number K100590.

Who is the listed applicant for EDGE CO2 LASER SYSTEM?

The FDA 510(k) record lists Jm System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDGE CO2 LASER SYSTEM?

The FDA product code for EDGE CO2 LASER SYSTEM is ONG.

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 Jm System Co., 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.

K100098PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE

Related Devices (Code: ONG)

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.

K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.K244060eCO2 3DLutronic CorporationK251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.K233550MOSAIC 3D (Surgical Laser)Lutronic AestheticK223871Miria Skin Treatment SystemAVAVA, Inc.

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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