# K123071: Vashe Skin and Wound Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Puricore, Inc.
- Decided: Jan 24, 2013 after 115 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: 6 generations back to K830708 (1983). 16 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102945: Pediacyn Atopic Dermatitis Hydrogel, Oculus Innovative Sciences, Inc. (2011) Summary page 1.

## Most influential descendants
- K141863: Puricore Wound Hydrogel Spray Dressing (2015), 10 descendants of its own
- K150799: Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel,  Puracyn (R) Plus Antimicrobial Hydrogel Professional Formula (2015), 9 descendants of its own
- K160095: Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz (2016), 3 descendants of its own
- K181074: Simple Science Antimicrobial Facial and Eyelid Cleanser (2018), 2 descendants of its own
- K233399: Microdacyn Wound Care Solution (2024), 1 descendant of its own

## Indications for use
Vashel Skin and Wound Hydrogel - For Professional Use Only Under the supervision of a health care professional, Vashel Skin and Wound Hydrogel is indicated for the management and relief of pain, burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis, as well as for the relief of pain from first and second degree burns, and aids to relieve dry waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.

Source page: https://510kreport.com/device/K123071
Methodology: https://510kreport.com/methodology