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FDA 510(k)

MATTIOLI PULSE TWO/THREE PLUS FAMILY

K-Number: K100053 · 2010-03-10

ApplicantMattioli Engineering Corp.
Decision Date2010-03-10
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MATTIOLI PULSE TWO/THREE PLUS FAMILY is the device name listed in this FDA 510(k) record. The listed applicant is Mattioli Engineering Corp.. It received FDA 510(k) clearance on 2010-03-10 under 510(k) number K100053. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MATTIOLI PULSE TWO/THREE PLUS FAMILY?

MATTIOLI PULSE TWO/THREE PLUS FAMILY is a medical device that received FDA 510(k) clearance on 2010-03-10. The listed applicant is Mattioli Engineering Corp.. The 510(k) number is K100053.

When did MATTIOLI PULSE TWO/THREE PLUS FAMILY receive FDA 510(k) clearance?

MATTIOLI PULSE TWO/THREE PLUS FAMILY received FDA 510(k) clearance on 2010-03-10, under 510(k) number K100053.

Who is the listed applicant for MATTIOLI PULSE TWO/THREE PLUS FAMILY?

The FDA 510(k) record lists Mattioli Engineering Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MATTIOLI PULSE TWO/THREE PLUS FAMILY?

The FDA product code for MATTIOLI PULSE TWO/THREE PLUS FAMILY is ONF.

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Other records listing Mattioli Engineering Corp. as applicant

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Related Devices (Code: ONF)

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.

K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser 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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