Data / Medical devices / China / Shenzhen Rainbow Light Medical Equipment Co., Ltd
Shenzhen Rainbow Light Medical Equipment Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Rainbow Light Medical Equipment Co., Ltd is registered with the FDA (registration 3048610148) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 16, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3048610148
- Address
- 101-1, 2, 3, and 4 floors, 132-1 Dayang Road Rentian Community, Fuhai Street, Bao'an District, Shenzhen Guangdong, China, 518000
- Owner or operator
- Shenzhen Rainbow Light Medical Equipment Co., Ltd (10096209)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- July 22, 2026
- Registered through
- 2027
- Brand names listed
- Kala Eclipse Elite Panel(Model:KA-480), Kala Eclipse Pro Panel(Model:KA-240), MitoGLOW Mask (Model: MJ-252), Smart Triad 3LT shoulder, UNICLED 5 CENTURION KOREAN MASK (Model: MJ-19)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Exporter to the US | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 16, 2023 | K223893 | Infrared Heat (Model: E0221) | OHS | Substantially Equivalent | Light Tree Ventures Europe B.V. | accessdata.fda.gov |
| December 20, 2022 | K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) | OHS | Substantially Equivalent | Light Tree Ventures Europe B.V. | accessdata.fda.gov |
Compare with other makers
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Lamp, Infrared, Therapeutic Heating
Updated May 16, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.