# K972597: PMT New Beginnings Gelshapes & Amend

- Pathway: 510(k) (Traditional)
- Applicant: Pmt Corp.
- Decided: Oct 1, 1997 after 82 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 its predicate without a number.
- (no number) ReJuveness: named in the summary without a submission number
- (no number) McGhan Medical Corporation: named in the summary without a submission number
- (no number) Geligne Medical: named in the summary without a submission number
- (no number) Medical Z: named in the summary without a submission number
- (no number) CUI Corporation: named in the summary without a submission number
- (no number) Biodermis: named in the summary without a submission number

## Most influential descendants
- K013732: Gelzone (2002), 0 descendants of its own

## Indications for use
Management of hypertrophic and keloid scars.

Source page: https://510kreport.com/device/K972597
Methodology: https://510kreport.com/methodology