C.C. Life 21

FDA 510(k) K230459 · 21 Equipment S.R.L.

Substantially Equivalent

510(k) numberK230459

Submission

Device name
C.C. Life 21
Applicant
21 Equipment S.R.L.
Torino, IT
Received
February 21, 2023
Decision date
October 19, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

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More from Shenzhen Qianyu Technology Co., Ltd.

510(k)DeviceDecision
K213295C.C. Life 21PBX · Traditional 11/17/2022SE

Questions and answers

When was C.C. Life 21 cleared by the FDA?

C.C. Life 21 (K230459) received a 510(k) decision of Substantially Equivalent on October 19, 2023, 240 days after the submission was received.

What is the product code of K230459?

The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.