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FDA 510(k)

SLIM E30 II CO2 LASER

K-Number: K110984 · 2011-07-22

ApplicantLasering S.R.L.
Decision Date2011-07-22
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SLIM E30 II CO2 LASER is the device name listed in this FDA 510(k) record. The listed applicant is Lasering S.R.L.. It received FDA 510(k) clearance on 2011-07-22 under 510(k) number K110984. 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 SLIM E30 II CO2 LASER?

SLIM E30 II CO2 LASER is a medical device that received FDA 510(k) clearance on 2011-07-22. The listed applicant is Lasering S.R.L.. The 510(k) number is K110984.

When did SLIM E30 II CO2 LASER receive FDA 510(k) clearance?

SLIM E30 II CO2 LASER received FDA 510(k) clearance on 2011-07-22, under 510(k) number K110984.

Who is the listed applicant for SLIM E30 II CO2 LASER?

The FDA 510(k) record lists Lasering S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLIM E30 II CO2 LASER?

The FDA product code for SLIM E30 II CO2 LASER is ONG.

Related Clinical Trials

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Other records listing Lasering S.R.L. 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.

K063001SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIESK063396VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES

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

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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