K102942 - CORELEADER ALGIPLASTER MODEL AP 050501 (FDA 510(k) Clearance)

K102942 is an FDA 510(k) clearance for the CORELEADER ALGIPLASTER MODEL AP 050501. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Coreleader Biotech Co., Ltd. (Taipei, Taiwan, TW). The FDA issued a Cleared decision on June 22, 2011 after a review of 261 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.

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