Skip to content

Coapt Systems, Inc.

United StatesFDA applicant, unverified

Devices
17
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Coapt Systems, Inc. makes

Coapt Systems, Inc. manufactures medical devices for soft tissue augmentation and facial contouring, including the Endotine series for midface, chin, and forehead augmentation, as well as transblepharal (under-eye) correction. The portfolio also includes gel-based fillers like VF Gel Plus and Liquigel, designed for temporary volume restoration. Ribbon-style implants and forehead-specific devices complete the product line, targeting areas such as the under-eyes and midface.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) database, adhering to U.S. medical device compliance requirements. Coapt Systems, Inc. is headquartered in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue17

Newest first, rows 1-17 of 17

Search and filter all 17 devices
Skip device list

  • Coapt Systems Endotine Device, Model Cfd-101-00197 Ref K023922

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vf Gel Plus Ref K071663

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vf Liquigel Ref K083783

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endotine Ribbon Ref K050611

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Coapt Endotine Midface-St 4.5 Device Ref K032698

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endotine Forehead Triple Device Ref K042078

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Coapt Endotine Chin 3.5 Device Ref K033524

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endotine Ribbon Ref K051415

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endotine Transbleph Device Ref K040740

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Coapt Systmes Endotine Device Ref K014153

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ultratine Forehead Ref K060249

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ultratine Transbleph Ref K060248

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endotine Transbleph 3.0/3.5 Device Ref K042796

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endotine Forehead Device Ref K032770

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endotine Midface B 4.5 Device Ref K041835

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modification To Vf Gel Plus Ref K080956

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modification To Endotine Ribbon Ref K060828

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-17 of 17

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Coapt Systems, Inc., initiated on 2003-05-23. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2003

    • 23 May 2003 Z-1002-03 Unclassified (pre-2012) Terminated During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury. Distribution: These products were distributed nationally to 107 consignees and internationally to 2 consignees via distributors and…
      Full distribution text These products were distributed nationally to 107 consignees and internationally to 2 consignees via distributors and directly to physicians and/or medical facilities. The total number of devices distributed subject to the removal by lot numbers: lot 00045: 19 units; lot 00085: 94 units; and lot 00092: 160 units. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, physicians and/or medical facilities who received the recalled products. There is no known U. S. Government or Canadian distribution.

Frequently asked questions

How many devices does Coapt Systems, Inc. have in the registry?

The registry currently lists 17 devices for Coapt Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Coapt Systems, Inc.'s devices?

Among its 17 most recently registered devices, Coapt Systems, Inc. has devices listed in FDA 510(k) (17 devices).

What risk classes do Coapt Systems, Inc.'s devices fall under?

Among its 17 most recently registered devices, the classes recorded for Coapt Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Coapt Systems, Inc.?

FDA recall records list 1 recall initiated by Coapt Systems, Inc., the most recent initiated on 23 May 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Coapt Systems, Inc. in the registry?

The most recently registered devices listed for Coapt Systems, Inc. include COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197, VF GEL PLUS, VF LIQUIGEL and ENDOTINE RIBBON.

Generated automatically from registry data and not verified by a human reviewer.