Manufacturer registered with FDA
Guangzhou Stars Pulse Co.,Ltd.
Guangzhou, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 29
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Guangzhou Stars Pulse Co.,Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Guangzhou Stars Pulse Co.,Ltd. | 3 device types | — | Below |
| Colombia | INVIMA | Manufacturer | GUANGZHOU STARS PULSE CO. LTD | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Guangzhou Stars Pulse Co.,Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | usmile C10 Portable Dental Flosser, models: C10 / C10 Blue / C10 White / C10 Inkstone Black / C10 Violet Mistusmile C30 Portable Dental Flosser, models: usmile C30 / usmile C30 Shadow Black / usmile C30 usmile Blue / usmile C30usmile C30 SE Portable Dental Flosser, Models: USM111 Cloud White / USM111 Slate Black / USM111 Mist Pinkusmile C50 Portable Dental Flosser, models: usmile C50 / usmile C50 Bronze Gold / usmile C50 Obsidian Blackusmile, usmile Dual-Line Nozzle For Water Flosser, Nozzleusmile, usmile Standard Nozzle for Water Flosser, CN-001usmile, usmile Wave Liquid Flosser Easy Flossing Nozzle, CN-004 | 2021 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Soft Clean Brush Head for Kids, Model PET01Toothbrush for Kids usmile Q10, Model usmile Q10usmile, Advanced Whitening Brush Head, PCK-002usmile, D50 OralCam Electric Toothbrush, D50usmile, MINI Full-Effect Cleaning Brush Head, Model: PET04usmile, P10S Electric Toothbrush Midnight Blue, P10Susmile, P10S Electric Toothbrush Misty White, P10Susmile, P20 PRO Oscillating Vibrating Electric Toothbrush, usmile P20 PROusmile, Professional Clean Brush Head, Model PRO01usmile, Professional Clean Brush Head, Model PRO61, Color pink 10 moreusmile, Soft Sensitive Brush Head, Model PRO03usmile, Sonic Electric Toothbrush, Model Y10 PROusmile, usmile Kids Smart Toothbrush, usmile Q30usmile, Usmile P10 Sonic Electric Toothbrush, P10usmile, usmile Sonic Electric Toothbrush P10 PRO, P10PROusmile, Usmile, Cushioned Whitening Brush Head, Model: PCK-006usmile, Usmile, Cushioned Whitening Brush Head, Model: PCK-010usmile, Whitening Brush Head, Model PCB01, Color blackusmile, Whitening Brush Head, Model PCB01, Color whiteusmile, Y20 PRO Smart Electric Toothbrush, Model Y20 PROS | 2020 |
| Plaque Disclosing KitNYH · Class 2 | — | Maker | D-lite OralCam, Models: USM057usmile, D50 OralCam Electric Toothbrush, MOD: USM551, USM521 | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Guangzhou Stars Pulse Co., Ltd.FDA reg. 3015527463 | Guangzhou Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060686). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.