Cleared Traditional

K102942 - CORELEADER ALGIPLASTER MODEL AP 050501

K102942 · Coreleader Biotech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
261d
Days
-
Risk

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.

FDA 510(k) Submission Details - K102942

510(k) Number K102942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2010
Decision Date June 22, 2011
Days to Decision 261 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 115d · This submission: 261d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 638
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K102942.
TL-CERMIDE SKIN BARRIER EMULSION
K110757 · Trigen Laboratories, Inc. · Aug 2011
MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY
K110546 · Derma Sciences, Inc. · Jul 2011
ADVANCIS ACTIVON TUBE
K101114 · Advancis Medical · Jul 2011
ELTA WOUND CLEANSER
K103713 · Swiss American Products, Inc. · Jun 2011
EMULSION SB
K110732 · Prugen IP Holdings, Inc. · Jun 2011
EXSALT SD7 WOUND DRESSING
K103067 · Exciton Technologies, Inc. · May 2011