Guangdong Ace-Tec Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3008345424
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Guangdong Ace-Tec Co., Ltd. makes
Guangdong Ace-Tec Co., Ltd. manufactures LED therapy masks, including models such as the SR11CM series, designed for non-invasive skin treatments and light-based therapies.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the US.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) Ref K252994
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3008345424
- DUNS number
- 528189557
- Address
- No.420, Jinxing Road, Xixi Industrial Park, Liaobu Town, Dongguan Guangdong
Frequently asked questions
How many devices does Guangdong Ace-Tec Co., Ltd. have in the registry?
The registry currently lists 10 devices for Guangdong Ace-Tec Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Guangdong Ace-Tec Co., Ltd.'s devices?
Among its 10 most recently registered devices, Guangdong Ace-Tec Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Guangdong Ace-Tec Co., Ltd.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Guangdong Ace-Tec Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Guangdong Ace-Tec Co., Ltd. in the registry?
The most recently registered devices listed for Guangdong Ace-Tec Co., Ltd. include ACE-TEC SR11CM, ACE-TEC SR11CM1, ACE-TEC SR11CM2 and ACE-TEC SR11CM3.