# K180305: Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)

- Pathway: 510(k) (Traditional)
- Applicant: Aquilabs Us, LLC
- Decided: Apr 13, 2018 after 70 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: 10 generations back to K914579 (1992). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133542: Puracyn Plus Skin and Wound, Innovacyn, Inc. (2014) Summary page 5.
- K123072: Vashe Wound Therapy Solution, Puricore, Inc. (2013) Summary page 5.
- K113693: Nixall TM Wound and Skin Care, Seriously Clean, Ltd. (2012) Summary page 5.
- K113820: Neutrophase Antimicrobial Wound Cleanser, Novabay Pharmaceuticals (2012) Summary page 5.

## Indications for use
OTC Indications: Hychloderm Wound and Skin Care (OTC) is intended for over-the-counter use in the management of minor irritations, minor cuts, minor abrasions, minor burns, minor lacerations, and intact skin and lubrication absorbent wound dressings. Rx-only Indications: Hychloderm Wound and Skin Care (Rx) is intended for use by healthcare professionals for management of minor irritations, minor cuts, minor abrasions, minor lacerations, cleansing, irrigating, moistening, and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wound such as, stage I-IV pressure ulcers, diabetic foot ulcers, leg ulcers, 1st and 2nd degree burns, post-surgical wounds, and lubricating absorbent wound dressings.

Source page: https://510kreport.com/device/K180305
Methodology: https://510kreport.com/methodology