Myoscience, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Myoscience, Inc. makes
Myoscience, Inc. manufactures cryotherapy devices designed for localized tissue treatment, including the CRYO-TOUCH II, CRYO-TOUCH III, and CRYO-TOUCH IV systems. These devices are intended for controlled cold therapy applications, such as soft tissue procedures and cosmetic treatments. The iovera system, also part of the portfolio, is used for targeted tissue ablation via cryoablation techniques. All products are intended for medical and aesthetic use under professional supervision.
The company’s devices fall under FDA Class II regulation and are listed via the 510(k) clearance pathway. These products are intended for use in the United States. No additional regulatory registries or international listings are specified.
Catalogue
Iovera Ref K133453
Regimes: 510(k) Registry: 510(k)iovera system Ref K173763
Regimes: 510(k) Registry: 510(k)Cryo-Touch Iii Ref K120415
Regimes: 510(k) Registry: 510(k)iovera system Ref K161835
Regimes: 510(k) Registry: 510(k)Myoscience iovera system Ref K142866
Regimes: 510(k) Registry: 510(k)Myoscience Cryo-Touch Ref K083493
Regimes: 510(k) Registry: 510(k)Myoscience Cryo-Touch Ref K100447
Regimes: 510(k) Registry: 510(k)Cryo-Touch Iv Ref K123516
Regimes: 510(k) Registry: 510(k)Cryo-Touch Ii Ref K102021
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Myoscience, Inc., the earliest on 2013-06-21 and the most recent on 2015-07-01. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 1 Jul 2015 Z-2201-2015 Class II Terminated The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05.
2013
- 21 Jun 2013 Z-1781-2013 Class II Terminated The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only.
Frequently asked questions
How many devices does Myoscience, Inc. have in the registry?
The registry currently lists 9 devices for Myoscience, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Myoscience, Inc.'s devices?
Among its 9 most recently registered devices, Myoscience, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Myoscience, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Myoscience, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Myoscience, Inc.?
FDA recall records list 2 recalls initiated by Myoscience, Inc., the most recent initiated on 1 Jul 2015. 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 Myoscience, Inc. in the registry?
The most recently registered devices listed for Myoscience, Inc. include IOVERA, iovera system, CRYO-TOUCH III and Myoscience iovera system.