# K102942: Coreleader Algiplaster Model AP 050501

- Pathway: 510(k) (Traditional)
- Applicant: Coreleader Biotech Co., Ltd.
- Decided: Jun 22, 2011 after 261 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953497 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910059: Kaltostat Wound Dressing, Calgon Vestal Div. (1991) Summary page 1.
- K983519: Comfeel Seasorb Dressing, Coloplast Corp. (1998) Summary page 1.

## Indications for use
The following conditions are considered appropriate for OTC use by the lay person: Coreleader AlgiPlaster is indicated for the management minor abrasions, minor cuts and minor lacerations. The following conditions are considered appropriate for Prescription Use under the supervision of a licensed healthcare provider: Coreleader Algilaster is indicated as a primary dressing for the management of exuding wounds, including acute wounds such as abrasions, lacerations and post-surgical wounds.

Source page: https://510kreport.com/device/K102942
Methodology: https://510kreport.com/methodology