510(k) · Cleared

Cleared

Perma Facial Implants

K071823510(k) TraditionalCleared Sep 19, 200778-day reviewClass II21 CFR 878.3500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Surgisil · ODU Facial Implant

Cleared on Sep 19, 2007 as substantially equivalent to K982688 (Spectrum Designs, Inc., 1998) and 3 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1998.

Decided: Sep 19, 2007
Review: 78 days
Class: Class II
Product code: ODU
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K983041 (1998). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK983041 Seare Biomedical Silicone SheetingSeare Biomedical Corp. · 1998
This deviceK071823 Perma Facial ImplantsSurgisil · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K983041	Seare Biomedical Silicone Sheeting	Seare Biomedical Corp.	1998	—
0 (this device)	K071823	Perma Facial Implants	Surgisil	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	2	0

FIG. 1 — Lineage of K071823, 1998–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ODU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K982688	Spectrum Designs Pre-Form Contour Silicone Carving Block Summary page 1 …nose, and throat synthetic polymer material 3. PREDICATE DEVICES • Spectrum Designs Pre-Form Contour Silicone Carving Block, Spectrum Designs (K982688) * AART Silicone Carving Block, Aesthetic and Reconstructive Technologies, Inc. (K021820) * Seare Bi…	Spectrum Designs, Inc.	1998	—
*	K021820	Aart Silicone Carving Block Summary page 1 …Contour Silicone Carving Block, Spectrum Designs (K982688) * AART Silicone Carving Block, Aesthetic and Reconstructive Technologies, Inc. (K021820) * Seare Biomedical Silicone Sheeting, Seare Biomedical Corporation (K983041) * AART Silicone Sheeting, Aesthet…	Aesthetic and Reconstructive Technologies, Inc.	2002	1
*	K983041	Seare Biomedical Silicone Sheeting Summary page 1 …Silicone Carving Block, Aesthetic and Reconstructive Technologies, Inc. (K021820) * Seare Biomedical Silicone Sheeting, Seare Biomedical Corporation (K983041) * AART Silicone Sheeting, Aesthetic and Reconstructive Technologies, Inc. (K022223) 4. DEVICE DESCRIPTI…	Seare Biomedical Corp.	1998	—
*	K022223	Aart Silicone Sheeting Summary page 1 …Seare Biomedical Silicone Sheeting, Seare Biomedical Corporation (K983041) * AART Silicone Sheeting, Aesthetic and Reconstructive Technologies, Inc. (K022223) 4. DEVICE DESCRIPTION The SurgiSilTM Perma Facial Implants are injection-molded (pre-formed) silicone implants…	Aesthetic and Reconstructive Technologies, Inc.	2002	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 4 ancestors has a recall of any class.

How does its category compare?

All ODU devices

ODU Facial Implant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · ODU

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODU

Too few ODU 510(k)s in any year since 2007 to give a median.

Recalls per year · ODU

No recall names ODU since 2007.

Adverse event reports per year · ODU

2in 2023

2007high 3 (2022) · low 0 (2007)2025

MAUDE reports naming product code ODU, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	1
2019	0	—	0
2020	0	—	0
2021	0	—	2
2022	0	—	3
2023	0	—	2
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Perma Facial Implants are solid silicone implants that are intended for use in

plastic and reconstructive surgery. The devices can be used for cosmetic

augmentation and corrections in the face, including areas such as the nose, chin,

and cheeks.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071823 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071823: Perma Facial Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071823

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026