# K974380: Rejuveness

- Pathway: 510(k) (Traditional)
- Applicant: Rejuveness Pharamceuticals, Inc.
- Decided: Apr 3, 1998 after 164 days
- Product code: MDA (Elastomer, Silicone, For Scar Management)
- Device class: 1
- Regulation: 21 CFR 878.4025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K982036: Silon Scar Strips (1998), 2 descendants of its own
- K023136: Oleeva Fabric (2002), 1 descendant of its own
- K024160: Neosporin Scar Solution (2003), 0 descendants of its own
- K991970: Scarease Sheets & Scarease Gel (1999), 0 descendants of its own
- K990651: Skin 2 Forte Silicone Sheeting (1999), 0 descendants of its own

## Indications for use
MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS o ReJuveness™ is effective in the management of hypertrophic and keloid scars. e Consistent use of ReJuveness ™ can reduce hypertrophic and keloid scarring. PREVENTION OF HYPERTROPHIC AND KELOID SCARS e ReJuveness may be useful as a prophylaxis on closed scars to aid in the prevention of hypertrophic and keloid scarring. ¢ Ifused following surgical procedures, ReJuveness™ may prevent hypertrophic and keloid scamming. ¢ Reluveness™ can be used as soon as the wound is closed, dry and the sutures have been removed. RelJuveness™ may prevent scarnng disorders.

Source page: https://510kreport.com/device/K974380
Methodology: https://510kreport.com/methodology