Shanghai Omni Laser Skinology Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 4
What Shanghai Omni Laser Skinology Co., Ltd. makes
Shanghai Omni Laser Skinology Co., Ltd. manufactures laser and light-based devices for cosmetic and dermatological treatments, including a diode laser system for hair removal, an IPL (intense pulsed light) device for painless hair reduction, and a phototherapy system for skin conditions.
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
- Registry: GUDID
Diode Laser Hair Removal System (RD-SLD600) Ref K223778
Regimes: 510(k) Registry: 510(k)Painless IPL System - KDT750 Ref K220214
Regimes: 510(k) Registry: 510(k)Phototherapy System (OL-PDT950) Ref K230342
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 560463241
Frequently asked questions
How many devices does Shanghai Omni Laser Skinology Co., Ltd. have in the registry?
The registry currently lists 4 devices for Shanghai Omni Laser Skinology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shanghai Omni Laser Skinology Co., Ltd.'s devices?
Among its 4 most recently registered devices, Shanghai Omni Laser Skinology Co., Ltd. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Shanghai Omni Laser Skinology Co., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Shanghai Omni Laser Skinology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shanghai Omni Laser Skinology Co., Ltd. in the registry?
The most recently registered devices listed for Shanghai Omni Laser Skinology Co., Ltd. include Omni Laser KDT750, Diode Laser Hair Removal System (RD-SLD600), Painless IPL System - KDT750 and Phototherapy System (OL-PDT950).