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FDA 510(k)

MLS, ZERONA-AD

K-Number: K120257 · 2012-05-14

ApplicantErchonia Medical, Inc.
Decision Date2012-05-14
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MLS, ZERONA-AD is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Medical, Inc.. It received FDA 510(k) clearance on 2012-05-14 under 510(k) number K120257. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MLS, ZERONA-AD?

MLS, ZERONA-AD is a medical device that received FDA 510(k) clearance on 2012-05-14. The listed applicant is Erchonia Medical, Inc.. The 510(k) number is K120257.

When did MLS, ZERONA-AD receive FDA 510(k) clearance?

MLS, ZERONA-AD received FDA 510(k) clearance on 2012-05-14, under 510(k) number K120257.

Who is the listed applicant for MLS, ZERONA-AD?

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

What is the FDA product code for MLS, ZERONA-AD?

The FDA product code for MLS, ZERONA-AD is OLI.

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Other records listing Erchonia Medical, Inc. as applicant

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Related Devices (Code: OLI)

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.

K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.K243854Contour Light (CL-100)Contour Research, LLCK252574Erchonia CLX (Model # CFL)Erchonia CorporationK252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.K243811Erchonia Zerona® VZ8Erchonia Corporation

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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