Cleared Traditional

K974380 - REJUVENESS

K974380 is an FDA 510(k) clearance for REJUVENESS, manufactured by Rejuveness Pharamceuticals, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K974380 · Rejuveness Pharamceuticals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
164d
Days
Class 1
Risk

K974380 is an FDA 510(k) clearance for the REJUVENESS. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Rejuveness Pharamceuticals, Inc. (Ballston Spa, US). The FDA issued a Cleared decision on April 3, 1998 after a review of 164 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - 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. Standard predicate reliance. 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.

View all Rejuveness Pharamceuticals, Inc. devices

FDA 510(k) Submission Details - K974380

510(k) Number K974380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1997
Decision Date April 03, 1998
Days to Decision 164 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
49d slower than avg
Panel avg: 115d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

MDA Device Classification - Class 1, General Controls

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MDA Elastomer, Silicone, For Scar Management

All 41
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K974380.
SPENCO SILICONE GEL SHEET
K981902 · Spenco Medical Corp. · Jun 1998
EVANESCE SCAR MANAGEMENT SYSTEM
K981387 · Medical Scientific, Inc. · Jun 1998
SKAR-KARE SHEET
K980563 · Life Medical Sciences, Inc. · May 1998
SILGEL TOPICAL GEL SHEET
K974172 · Nagor , Ltd. · Mar 1998
KMC NEWSKIN
K974143 · Kmc Intl. Co. · Mar 1998
MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE
K974354 · Sca Molnlycke · Mar 1998