510(k) · Cleared

Cleared

Scarease Sheets & Scarease Gel

K991970510(k) TraditionalCleared Oct 25, 1999136-day reviewClass I21 CFR 878.4025

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

Pillar Surgical · MDA Elastomer, Silicone, For Scar Management

Cleared on Oct 25, 1999 as substantially equivalent to K974354 (Sca Molnlycke, 1998) and 3 other predicates after a 136-day review. Its family tree reaches back 1 generation to 1994.

Decided: Oct 25, 1999
Review: 136 days
Class: Class I
Product code: MDA
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K935499 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK935499 PMT Silicone SheetingPmt Corp. · 1994
This deviceK991970 Scarease Sheets & Scarease GelPillar Surgical · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935499	PMT Silicone Sheeting	Pmt Corp.	1994	—
0 (this device)	K991970	Scarease Sheets & Scarease Gel	Pillar Surgical	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	2	0

FIG. 1 — Lineage of K991970, 1994–1999Source: 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 MDA? 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
*	K974354	Mepiform Adherent Silicone Dressing for Scar Care Summary page 1 …and/or flatten scars. Substantial Equivalence ScarEase Sheets are substantially equivalent Predicate Devices: Mepiform Adherent Silicone Dressing for Scar Care, 510(k) K974354; PMT Silicone Sheeting K935499; and Rejuveness K974380. Predicate Device for ScarEase Adhesive Gel is Kelocote K973572. ScarEase…	Sca Molnlycke	1998	—
*	K935499	PMT Silicone Sheeting Summary page 1 …ial Equivalence ScarEase Sheets are substantially equivalent Predicate Devices: Mepiform Adherent Silicone Dressing for Scar Care, 510(k) K974354; PMT Silicone Sheeting K935499; and Rejuveness K974380. Predicate Device for ScarEase Adhesive Gel is Kelocote K973572. ScarEase is made from identical liquid p…	Pmt Corp.	1994	—
*	K974380	Rejuveness Summary page 1 …e Sheets are substantially equivalent Predicate Devices: Mepiform Adherent Silicone Dressing for Scar Care, 510(k) K974354; PMT Silicone Sheeting K935499; and Rejuveness K974380. Predicate Device for ScarEase Adhesive Gel is Kelocote K973572. ScarEase is made from identical liquid polysiloxane and/or elast…	Rejuveness Pharamceuticals, Inc.	1998	—
*	K973572	Kelocote Scar Gel and Kelocote Laser Gel Summary page 1 …m Adherent Silicone Dressing for Scar Care, 510(k) K974354; PMT Silicone Sheeting K935499; and Rejuveness K974380. Predicate Device for ScarEase Adhesive Gel is Kelocote K973572. ScarEase is made from identical liquid polysiloxane and/or elastomer materials and manufacturing processes as the predicate devi…	Hanson Medical, Inc.	1997	—

Also cleared against K974354: 1 other device →

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?

None of the 4 ancestors has a recall.
1 other device also cites its predicate K974354.

How does its category compare?

All MDA devices

MDA Elastomer, Silicone, For Scar Management: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MDA

2in 2011

2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MDA

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

Recalls per year · MDA

No recall names MDA since 2007.

Adverse event reports per year · MDA

3in 2025

2007high 8 (2023) · low 0 (2008)2025

MAUDE reports naming product code MDA, 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	0	—	3
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	2	—	0
2012	0	—	0
2013	0	—	2
2014	0	—	1
2015	0	—	2
2016	0	—	5
2017	0	—	3
2018	0	—	2
2019	0	—	5
2020	0	—	4
2021	0	—	3
2022	0	—	0
2023	0	—	8
2024	0	—	0
2025	0	—	3
2026	0	—	—

What is it indicated for?

ScarEase Sheets and Gel are indicated for use in the management of hypertrophic and keloid scars.

ScarEase Sheets and Gel may prevent hypertrophic and keloid scarring.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K991970 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991970: Scarease Sheets & Scarease Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991970

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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