Cleared Traditional

THE BIBICURE SYS DERMEPIL NATURAL HAIR (K843543) - FDA 510(k) Clearance

K843543 · Les Entreprises Bibi, Inc. · General & Plastic Surgery device
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Nov 1984
Decision
61d
Days
-
Risk

K843543 is an FDA 510(k) clearance for the THE BIBICURE SYS DERMEPIL NATURAL HAIR.

Submitted by Les Entreprises Bibi, Inc. (Montreal H2n1a4, CA). The FDA issued a Cleared decision on November 7, 1984 after a review of 61 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 Les Entreprises Bibi, Inc. devices

Submission Details

510(k) Number K843543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1984
Decision Date November 07, 1984
Days to Decision 61 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
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -