# K122595: Hydropermeate Topical Emulsion, ANSWER2SKIN Sunburn Relief Cream, ANSWER2SKIN First Aid Cream

- Pathway: 510(k) (Traditional)
- Applicant: Dermal Life, LLC
- Decided: May 1, 2013 after 250 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: 1 generation back to K964240 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964240: Biafine Wound Dressing Emulsion, Medix Pharmaceuticals Americas, Inc. (1997) Summary page 1.

## Indications for use
HYDROPERMEATETM Topical Emulsion is intended to be used as a wound dressing for the following indications: * Full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers * Superficial wounds * 1st and 2nd degree burns, including sunburns * Dermal donor and graft site management * Radiation dermatitis * Minor abrasions ANSWER2SKNTM SUNBURN RELIEF Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor burns, including minor sunburns. ANSWER2SKINTM FIRST AID Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor superficial wounds and minor abrasions, including cuts and scrapes.

Source page: https://510kreport.com/device/K122595
Methodology: https://510kreport.com/methodology