Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DEKA PHYSIQ 360

K-Number: K231971 · 2023-09-26

ApplicantEl.En S.P.A.
Decision Date2023-09-26
Product CodePKT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEKA PHYSIQ 360 is a medical device manufactured by El.En S.P.A.. It received FDA 510(k) clearance on 2023-09-26 under approval number K231971. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEKA PHYSIQ 360?

DEKA PHYSIQ 360 is a medical device that received FDA 510(k) clearance on 2023-09-26. It is manufactured by El.En S.P.A.. The 510(k) number is K231971.

When was DEKA PHYSIQ 360 approved by the FDA?

DEKA PHYSIQ 360 received FDA 510(k) clearance on 2023-09-26, under approval number K231971.

What company makes DEKA PHYSIQ 360?

DEKA PHYSIQ 360 is manufactured by El.En S.P.A..

What is the FDA product code for DEKA PHYSIQ 360?

The FDA product code for DEKA PHYSIQ 360 is PKT.

Other Devices by El.En S.P.A.

K233470DEKA LILY K233090DEKA AGAIN PRO family K232334DEKA SIMON K241459MOTUS PRO Family K233473DEKA LOTUS K240752DEKA TORO

View all 14 devices →

Related Devices (Code: PKT)

K160470SculpSureCynosure, Inc. K171992SculpSureCynosure, Inc. K171111SculpsureCynosure, Inc. K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd. K180511Eon FRDominion Aesthetic Technologies, Inc. K182741SculpSureCynosure

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.

↑