Cleared Traditional

K124064 - YOUNG AGAIN

K124064 is an FDA 510(k) clearance for YOUNG AGAIN, manufactured by Espansione Marketing S.P.A. The device is a Class 2 General & Plastic Surgery device with product code OHS cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K124064 · Espansione Marketing S.P.A · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
353d
Days
Class 2
Risk

K124064 is an FDA 510(k) clearance for the YOUNG AGAIN. Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Espansione Marketing S.P.A (Imola(Bo), IT). The FDA issued a Cleared decision on December 19, 2013 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K124064

510(k) Number K124064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2012
Decision Date December 19, 2013
Days to Decision 353 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
238d slower than avg
Panel avg: 115d · This submission: 353d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OHS Device Classification - Class 2, Special Controls

Product Code OHS Light Based Over The Counter Wrinkle Reduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OHS Light Based Over The Counter Wrinkle Reduction

All 160
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