SkinSmart Antimicrobial HydroGel— 510(k) K254041
Substantially EquivalentMagic Science Supply, LLC
FDA 510(k) clearance K254041 for SkinSmart Antimicrobial HydroGel, Substantially Equivalent on 2026-09-11. Applicant: Magic Science Supply, LLC. Device class: Unclassified.
Summary
SkinSmart Antimicrobial HydroGel is a wound product under FRO, the code for drug wound dressings. The record doesn't name the active ingredient.
The device class is listed as U, for unclassified, with no regulation number. The advisory panel field reads Unknown, and the General and Plastic Surgery panel reviewed it as a Traditional 510(k).
Magic Science Supply filed from Edina, Minnesota. Review took 269 days (December 16, 2025 to September 11, 2026).
Clearance details
- Applicant
- Magic Science Supply, LLC
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edina, MN, US
Recent devices under product code FRO
view allAdverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.