# K123394: Coreleader Hydro-Healer Hydrocolloid Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Coreleader Biotech Co., Ltd.
- Decided: Jun 6, 2013 after 216 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) 3M™ Tegasorb™ Hydrocolloid Dressings: named in the summary without a submission number

## Indications for use
Coreleader Hydro-clear is indicted for the management of 1 and 2™ degree burns, chronic ulcers, surgical wounds, skin graft and donor sites. Patient with conditions listed below is considered appropriate for Over-The Counter Use (OTC): for the management of minor cuts, minor burns (1* degree burns), minor lacerations and minor cuts.

Source page: https://510kreport.com/device/K123394
Methodology: https://510kreport.com/methodology