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FDA 510(k)

ME

K-Number: K131649 · 2013-12-11

ApplicantSyneron Beauty , Ltd.
Decision Date2013-12-11
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ME is the device name listed in this FDA 510(k) record. The listed applicant is Syneron Beauty , Ltd.. It received FDA 510(k) clearance on 2013-12-11 under 510(k) number K131649. 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 ME?

ME is a medical device that received FDA 510(k) clearance on 2013-12-11. The listed applicant is Syneron Beauty , Ltd.. The 510(k) number is K131649.

When did ME receive FDA 510(k) clearance?

ME received FDA 510(k) clearance on 2013-12-11, under 510(k) number K131649.

Who is the listed applicant for ME?

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

What is the FDA product code for ME?

The FDA product code for ME is ONF.

Related PubMed Literature

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.

PMID: 42834824India's medical device regulatory framework: a decade of transformation, international harmonization, and the road to global competitiveness.Expert review of medical devices ()PMID: 42825233Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis.Neurosurgery practice ()PMID: 42749521Medical Device Safety Throughout the Product Lifecycle: Regulatory Frameworks, Digital Transformation, and the Role of Artificial Intelligence in Devices and Monitoring.Clinical therapeutics ()PMID: 42745015Lean-Agile Product Development in FDA Relevant and Regulated Medical Device Contexts.Therapeutic innovation & regulatory science ()

Other records listing Syneron Beauty , 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.

K123845ME

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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