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 wound dressings that contain a drug or antimicrobial. The record doesn't name the active ingredient.
The device class is listed as U, for unclassified. FDA has never issued a classification regulation for FRO dressings, so they clear through 510(k) against pre-amendment predicates and there's no CFR section to cite. The advisory panel field reads Unknown.
Magic Science Supply filed from Edina, Minnesota. Review took 269 days (December 16, 2025 to September 11, 2026). Long, but antimicrobial claims get a close read: FDA wants to know what the antimicrobial actually does and how the label describes it.
Clearance details
- Applicant
- Magic Science Supply, LLC
- Product code
- 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.