SPECCHIO
K-Number: K260647 · 2026-04-02
ApplicantEl.En S.P.A.
Decision Date2026-04-02
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SPECCHIO is a medical device manufactured by El.En S.P.A.. It received FDA 510(k) clearance on 2026-04-02 under approval number K260647. 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 SPECCHIO?
SPECCHIO is a medical device that received FDA 510(k) clearance on 2026-04-02. It is manufactured by El.En S.P.A.. The 510(k) number is K260647.
When was SPECCHIO approved by the FDA?
SPECCHIO received FDA 510(k) clearance on 2026-04-02, under approval number K260647.
What company makes SPECCHIO?
SPECCHIO is manufactured by El.En S.P.A..
What is the FDA product code for SPECCHIO?
The FDA product code for SPECCHIO is PBX.
Other Devices by El.En S.P.A.
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.