Cleared Traditional

PERMA FACIAL IMPLANTS (K071823) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071823 · Surgisil · General & Plastic Surgery device
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Sep 2007
Decision
78d
Days
Class 2
Risk

K071823 is an FDA 510(k) clearance for the PERMA FACIAL IMPLANTS. Classified as Facial Implant (product code ODU), Class II - Special Controls.

Submitted by Surgisil (North Attleboro, US). The FDA issued a Cleared decision on September 19, 2007 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3500 - the FDA general and plastic surgery device framework. 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 Surgisil devices

Submission Details

510(k) Number K071823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2007
Decision Date September 19, 2007
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODU Facial Implant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3500
Definition For Use In Plastic And Reconstructive Surgery. The Devices Can Be Used For Cosmetic Augmentation And Corrections Of Soft Tissue Deformities In The Face, Including Areas Such As The Nose, Chin, And Cheeks.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.