Data / Medical devices / China / Guangdong Carain Beauty Equipment Co., Ltd
Guangdong Carain Beauty Equipment Co., Ltd: FDA-registered device maker in Foshan Guangdong, China, 4 510(k) clearances
Guangdong Carain Beauty Equipment Co., Ltd is registered with the FDA (registration 3011568699) in Foshan Guangdong, China. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated October 29, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011568699
- Address
- Room901-2, Bldg No.8 of CIMC High-tech Manufacturing Center, Chanxing 1st Rd, Xianchong Village, Chencun Town, Shunde District, Foshan Guangdong, China, 528313
- Owner or operator
- GUANGDONG CARAIN BEAUTY EQUIPMENT (10048521)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 13, 2020
- Registered through
- 2027
- Brand names listed
- Collagen P.I.N., MRPen MicroSystem, SER Pen Carain MicroSystem (Model MP1209SP), SkinStylus Microsystem, SkinStylus SteriLock® Cartridge 12pin ( 10445);, SkinStylus SteriLock® Cartridge 36pin ( 10446);, SkinStylus SteriLock® Cartridge Hilo ( SL38679);, SkinStylus SteriLock® Cartridge MicroSystem ( 4501) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Microneedle Device | QAI | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 29, 2025 | K253153 | SER Pen Carain MicroSystem (MP1209SP) | QAI | Substantially Equivalent | Su-Ko Technologies, LLC | accessdata.fda.gov |
| October 9, 2024 | K241355 | SER Pen Carain MicroSystem (MP1209SP) | QAI | Substantially Equivalent | Su-Ko Technologies, LLC | accessdata.fda.gov |
| October 21, 2022 | K222199 | Collagen P.I.N. (Percutaneous Induction Needling) | QAI | Substantially Equivalent | Induction Therapies, LLC | accessdata.fda.gov |
| April 10, 2020 | K200044 | SkinStylus SteriLock MicroSystem | QAI | Substantially Equivalent | Esthetic Education, LLC | accessdata.fda.gov |
Compare with other makers
Updated October 29, 2025. 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.