Cleared Traditional

K843678 - CREAT BRAND SKIN EXPANDER

K843678 · Aesthetech Corp. · General & Plastic Surgery device
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Nov 1984
Decision
49d
Days
-
Risk

K843678 is an FDA 510(k) clearance for the CREAT BRAND SKIN EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Aesthetech Corp. (Paso Robles, US). The FDA issued a Cleared decision on November 6, 1984 after a review of 49 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 Aesthetech Corp. devices

Submission Details

510(k) Number K843678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1984
Decision Date November 06, 1984
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -

Regulatory Peers - LCJ Tissue Expander And Accessories

All 21
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K843678.
RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)
K884250 · Mentor Corp. · Jun 1989
MENTOR FLAT-SPAN
K862049 · Mentor Corp. · Jun 1986
MENTOR EXPANDER MAMMARY PROSTHESIS
K844813 · Mentor Corp. · May 1985
RADOVAN TISSUE EXPANDER
K842883 · Mentor Corp. · Aug 1984
SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE
K801042 · Dow Corning Corp. Healthcare Industries Materials · Jun 1980