Step UP Skin Laser, LLC
Country not established
- Devices
- 1
What Step UP Skin Laser, LLC makes
Step UP Skin Laser, LLC manufactures the New Era laser device, designed for skin rejuvenation and hair removal procedures. This system is intended for controlled laser energy delivery to target pigmentation, vascular lesions, and unwanted hair.
The New Era laser is classified as a Class II medical device under FDA regulations and has been cleared via the 510(k) pathway. The company is based in the United States.
Catalogue
New Era Ref K182604
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Step UP Skin Laser, LLC have in the registry?
The registry currently lists 1 device for Step UP Skin Laser, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Step UP Skin Laser, LLC's devices?
Among its 1 most recently registered device, Step UP Skin Laser, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Step UP Skin Laser, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Step UP Skin Laser, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Step UP Skin Laser, LLC in the registry?
The most recently registered devices listed for Step UP Skin Laser, LLC include New Era.