510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071823Substantially Equivalent

Perma Facial Implants

Surgisil, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071823 is the FDA 510(k) clearance record for PERMA FACIAL IMPLANTS, a class II device, cleared for Surgisil on under FDA product code ODU (Facial Implant). FDA's definition for product code ODU reads: "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". FDA records list one 510(k) clearance for Surgisil. As of , FDA records show no recalls naming K071823.

Clearance record

Decision date
Received
(78 days to decision)
Product code
ODU Facial Implant
Regulation
21 CFR 878.3500
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Surgisil 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODU

Trailing 12 months

FDA records hold no clearances under product code ODU in the trailing twelve months.

FDA records show no clearances under product code ODU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ODU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260