Sinclair Pharma US, Inc.

Irvine, CA, US

SINCLAIR PHARMA US, INC. appears in FDA device records in Irvine, CA. FDA records list 5 510(k) clearances between 2015-04-24 and 2020-03-27, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 5
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Sinclair Pharma US, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Silhouette Lift, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 5 510(k) clearances for Sinclair Pharma US, Inc. between 2015 and 2020. The busiest year on record is 2017, with 2. The most recent is 2020, with 1.

Clearances by year, as a table

510(k) clearance decisions for Sinclair Pharma US, Inc., by decision year
Year	Clearances
2015	1
2017	2
2019	1
2020	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K200140	Silhouette Instalift	GAM	Substantially Equivalent	2020-03-27
K191299	Silhouette Featherlift / Silhouette Lift	GAW	Substantially Equivalent	2019-06-14
K163676	Silhouette InstaLift	GAM	Substantially Equivalent	2017-06-16
K171005	Silhouette Featherlift	GAW	Substantially Equivalent	2017-05-03
K142061	SILHOUETTE INSTALIFT	GAM	Substantially Equivalent	2015-04-24

Registered establishments

FDA registered establishments for Sinclair Pharma US, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3007009755	3007009755	SINCLAIR PHARMA US, INC.	18 TECHNOLOGY DRIVE, Irvine, CA 92618 US	2026	GAM

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2208-2015	Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.	Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of risks and side effects. Therefore, it can potentially mislead the patient regarding the safety of the product.	Class II	2015-07-02	Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Sinclair Pharma US, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain