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FDA 510(k)

DEKA LOTUS

K-Number: K250281 · 2025-02-26

ApplicantEl.En S.P.A.
Decision Date2025-02-26
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEKA LOTUS is the device name listed in this FDA 510(k) record. The listed applicant is El.En S.P.A.. It received FDA 510(k) clearance on 2025-02-26 under 510(k) number K250281. 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 DEKA LOTUS?

DEKA LOTUS is a medical device that received FDA 510(k) clearance on 2025-02-26. The listed applicant is El.En S.P.A.. The 510(k) number is K250281.

When did DEKA LOTUS receive FDA 510(k) clearance?

DEKA LOTUS received FDA 510(k) clearance on 2025-02-26, under 510(k) number K250281.

Who is the listed applicant for DEKA LOTUS?

The FDA 510(k) record lists El.En S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA LOTUS?

The FDA product code for DEKA LOTUS is ONF.

Other records listing El.En S.P.A. 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.

K260647SPECCHIOK251432OloK243683Deka BluebeamK241459MOTUS PRO FamilyK240752DEKA TOROK233473DEKA LOTUS

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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.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.K240314MULA (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.

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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