Cleared Traditional

K230459 - C.C. Life 21

K230459 is an FDA 510(k) clearance for C.C. Life 21, manufactured by 21 Equipment S.R.L.. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K230459 · 21 Equipment S.R.L. · Neurology device
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Oct 2023
Decision
240d
Days
Class 2
Risk

K230459 is an FDA 510(k) clearance for the C.C. Life 21. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by 21 Equipment S.R.L. (Torino, IT). The FDA issued a Cleared decision on October 19, 2023 after a review of 240 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all 21 Equipment S.R.L. devices

FDA 510(k) Submission Details - K230459

510(k) Number K230459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2023
Decision Date October 19, 2023
Days to Decision 240 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 148d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFO Device Classification - Class 2, Special Controls

Product Code NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 53
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