Data / Medical devices / China / Tianjin Mastervision Technology Co., Ltd.
Tianjin Mastervision Technology Co., Ltd.: FDA-registered device maker in Wuqing District Tianjin, China, 1 510(k) clearance and 1 PMA approval
Tianjin Mastervision Technology Co., Ltd. is registered with the FDA (registration 3032010300) in Wuqing District Tianjin, China. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated August 5, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032010300
- Address
- 1st Floor No.15 Building. No. 89 Heyuan Road Jing-jin Technology Valley, Wuqing District Tianjin, China, 301700
- Owner or operator
- Tianjin MasterVision Technology Co., Ltd. (10092434)
- Roles
- Manufacturer
- First device listed
- January 7, 2025
- Registered through
- 2026
- Brand names listed
- Dilight, EyeSpace Bespoke, EyeSpace Scleral, SDJMASTERVISION
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact (Other Material) - Daily | HQD | 2 | Manufacturer | accessdata.fda.gov |
| Lens, Contact, Orthokeratology, Overnight | NUU | 3 | 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 22, 2024 | K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | HQD | Substantially Equivalent | Tianjin Mastervision Technology Co., Ltd. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 5, 2026 | P220015 | DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens | NUU | 0 | August 5, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact (Other Material) - Daily
- All makers of Lens, Contact, Orthokeratology, Overnight
Updated August 5, 2026. 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.