Cleared Traditional

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) (K180305) - FDA 510(k) Clearance

K180305 · Aquilabs Us, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
70d
Days
-
Risk

K180305 is an FDA 510(k) clearance for the Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Aquilabs Us, LLC (Medley, US). The FDA issued a Cleared decision on April 13, 2018 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aquilabs Us, LLC devices

Submission Details

510(k) Number K180305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2018
Decision Date April 13, 2018
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
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