AlloX2 Pro Tissue Expanders (K214124) - FDA 510(k) Clearance

K214124 is an FDA 510(k) clearance for the AlloX2 Pro Tissue Expanders. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Sientra, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on June 8, 2023 after a review of 525 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Sientra, Inc. devices