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FDA 510(k)

EQUINOX CO2 LASER

K-Number: K131903 · 2013-09-19

ApplicantEclipse Aesthetics, LLC
Decision Date2013-09-19
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EQUINOX CO2 LASER is the device name listed in this FDA 510(k) record. The listed applicant is Eclipse Aesthetics, LLC. It received FDA 510(k) clearance on 2013-09-19 under 510(k) number K131903. 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 EQUINOX CO2 LASER?

EQUINOX CO2 LASER is a medical device that received FDA 510(k) clearance on 2013-09-19. The listed applicant is Eclipse Aesthetics, LLC. The 510(k) number is K131903.

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

EQUINOX CO2 LASER received FDA 510(k) clearance on 2013-09-19, under 510(k) number K131903.

Who is the listed applicant for EQUINOX CO2 LASER?

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

What is the FDA product code for EQUINOX CO2 LASER?

The FDA product code for EQUINOX CO2 LASER 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 Eclipse Aesthetics, 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.

K122922E-BEAM ND: YAG LASER

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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