Cynosure, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000010200 FEI 1000120578
- Devices
- 728
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Cynosure B.V.NL
What Cynosure, LLC makes
Cynosure, LLC manufactures electrosurgical systems for surgical and dermatological procedures, including monopolar and bipolar reusable and single-use electrodes, handpieces, and applicators. Their portfolio also includes multi-modality skin treatment systems and dermatological laser devices, such as frequency-doubled solid-state and solid-state laser systems for skin contouring and tissue modification.
The company’s devices are classified under Class I, Class II, and Class IIb regulations, with listings in the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Catalogue
Search and filter all 728 devicesShowing 1-50 of 728
Company details
- EUDAMED SRN
- US-MF-000010200
- FDA FEI number
- 1000120578
- DUNS number
- 780318028
- EU VAT number
- NL826218520B01
- EUDAMED status
- Active
- EUDAMED registered name
- Cynosure LLC
- Registered address
- 5, Carlisle Road, 01886, Westford, United States
- Website
- www.cynosurelutronic.com
- PRRC contact
- Nirav Desai
FDA recalls
FDA recall records list 1 recall initiated by Cynosure, LLC, initiated on 2014-10-09. By recorded status: 1 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 9 Oct 2014 Z-0169-2015 Class II Terminated If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock
Full distribution text
- 9 Oct 2014 Z-0169-2015 Class II Terminated If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock
Frequently asked questions
How many devices does Cynosure, LLC have in the registry?
The registry currently lists 728 devices for Cynosure, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cynosure, LLC's devices?
Among its 50 most recently registered devices, Cynosure, LLC has devices listed in FDA 510(k) (2 devices) and FDA GUDID (48 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cynosure, LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Cynosure, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cynosure, LLC?
FDA recall records list 1 recall initiated by Cynosure, LLC, the most recent initiated on 9 Oct 2014. 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 Cynosure, LLC in the registry?
The most recently registered devices listed for Cynosure, LLC include TempSure System, PICOSURE WORKSTATION, MaxG 4mm Adapter 2520-0027 and ASSY, 25MM Massage Head, TempSure 100-7027-055.