Cleared Traditional

Derma-R Cream (Derma-R Cream) (K240722) - FDA 510(k) Clearance

K240722 · Raya Pharmaceuticals, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
186d
Days
-
Risk

K240722 is an FDA 510(k) clearance for the Derma-R Cream (Derma-R Cream). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Raya Pharmaceuticals, LLC (Kingsland, US). The FDA issued a Cleared decision on September 20, 2024 after a review of 186 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Raya Pharmaceuticals, LLC devices

Submission Details

510(k) Number K240722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2024
Decision Date September 20, 2024
Days to Decision 186 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 115d · This submission: 186d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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