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)

Symmed Elite Aesthetic

K-Number: K230412 · 2023-04-13

ApplicantTermosalud
Decision Date2023-04-13
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Symmed Elite Aesthetic is a medical device manufactured by Termosalud. It received FDA 510(k) clearance on 2023-04-13 under approval number K230412. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Symmed Elite Aesthetic?

Symmed Elite Aesthetic is a medical device that received FDA 510(k) clearance on 2023-04-13. It is manufactured by Termosalud. The 510(k) number is K230412.

When was Symmed Elite Aesthetic approved by the FDA?

Symmed Elite Aesthetic received FDA 510(k) clearance on 2023-04-13, under approval number K230412.

What company makes Symmed Elite Aesthetic?

Symmed Elite Aesthetic is manufactured by Termosalud.

What is the FDA product code for Symmed Elite Aesthetic?

The FDA product code for Symmed Elite Aesthetic is PBX.

Other Devices by Termosalud

K230659Zionic Aesthetic K223680Eneka Pro K241656Eneka Selectif K243488VMAT PRO

Related Devices (Code: PBX)

K162512truSculptCutera, Inc. K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc. K161551TR-100BTL Industries, Inc. K161043Profound SystemSyneron Candela Corporation K160329InMode System MiniFX HandpieceInmode MD , Ltd. K161199EndyMed Contour HandpieceEndymed Medical, 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.

↑