# K973572: Kelocote Scar Gel and Kelocote Laser Gel

- Pathway: 510(k) (Traditional)
- Applicant: Hanson Medical, Inc.
- Decided: Oct 21, 1997 after 32 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) Kelocote Gel of Allied Biomedical: named in the summary without a submission number

## Most influential descendants
- K991970: Scarease Sheets & Scarease Gel (1999), 0 descendants of its own

## Indications for use
KELOCOTE SCAR GEL: FOR THE MANAGEMENT OF HYPERTROPHIC SCARS AND KELOID SCARS AND ASSOCIATED ERYTHEMA SECONDARY TO ANY TRAUMA CAUSING SCARS KELOCOTE LASER GEL: FOR THE MANAGEMENT OF HYPERTROPHIC SCARS AND KELOID SCARS AND ERYTHEMA SECONDARY TO LASER RESURFACING

Source page: https://510kreport.com/device/K973572
Methodology: https://510kreport.com/methodology