Cooltouch, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Cooltouch, Inc. makes
Cooltouch, Inc. manufactures laser-based medical devices, including the COOLTOUCH VARIA Nd:YAG laser system and the COOLTOUCH Model NS 160, designed for dermatological and aesthetic treatments.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Cooltouch Nd:yag Laser System, Cooltouch-Ii Nd:yag Laser System, Model Cooltouch, Cooltouch Ii Ref K003715
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Cooltouch Varia-Ii Nd:yag Laser System Ref K003781
Regimes: 510(k) Registry: 510(k)Cooltouch Varia Nd:yag Laser System Ref K060966
Regimes: 510(k) Registry: 510(k)Cooltouch And Cooltouch-Ii Nd:yag Laser Systems Ref K014035
Regimes: 510(k) Registry: 510(k)Cooltouch, Model Ns 160 Ref K040921
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cooltouch, Inc. have in the registry?
The registry currently lists 6 devices for Cooltouch, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cooltouch, Inc.'s devices?
Among its 6 most recently registered devices, Cooltouch, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Cooltouch, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Cooltouch, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cooltouch, Inc. in the registry?
The most recently registered devices listed for Cooltouch, Inc. include COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II, COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM, COOLTOUCH VARIA-II ND:YAG LASER SYSTEM and COOLTOUCH VARIA ND:YAG LASER SYSTEM.