BEAU RX SCAR CARE GEL— 510(k) K083718

Substantially Equivalent

Beau RX Solutions, LLC

FDA 510(k) clearance K083718 for BEAU RX SCAR CARE GEL, Substantially Equivalent on 2009-01-26. Applicant: Beau RX Solutions, LLC. Device class: 1.

Clearance details

Applicant: Beau RX Solutions, LLC
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 2008-12-15
Decision date: 2009-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne Beach, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MDA

K112131 — NEODYNE DRESSING2011-09-29
K111733 — CORELEADER SCAR-DIMMER2011-09-22
K053481 — KELO-COTE SPRAY2006-04-14
K041704 — NEWGEL AND NEWGEL PLUS E2005-10-17
K040307 — HANSON SCAR ADE2004-08-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.