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FDA 510(k)

SMAXEL CO2 Surgical Laser System

K-Number: K180036 · 2018-02-02

ApplicantIds, Ltd.
Decision Date2018-02-02
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMAXEL CO2 Surgical Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Ids, Ltd.. It received FDA 510(k) clearance on 2018-02-02 under 510(k) number K180036. 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 SMAXEL CO2 Surgical Laser System?

SMAXEL CO2 Surgical Laser System is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is Ids, Ltd.. The 510(k) number is K180036.

When did SMAXEL CO2 Surgical Laser System receive FDA 510(k) clearance?

SMAXEL CO2 Surgical Laser System received FDA 510(k) clearance on 2018-02-02, under 510(k) number K180036.

Who is the listed applicant for SMAXEL CO2 Surgical Laser System?

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

What is the FDA product code for SMAXEL CO2 Surgical Laser System?

The FDA product code for SMAXEL CO2 Surgical Laser System is ONG.

Other records listing Ids, 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.

K233018PICOSECOND Nd:YAG Laser SystemK222485SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG LaserK181868SHINY RPL SystemK171079Q-Switched Nd:YAG Laser System

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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