Data / Medical devices / South Korea / Recensmedical Inc.
Recensmedical Inc.: FDA-registered device maker in Hwaseong-si Gyeonggi, South Korea, 3 510(k) clearances
Recensmedical Inc. is registered with the FDA (registration 3015351183) in Hwaseong-si Gyeonggi, South Korea. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 16, 2025. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015351183
- Address
- 3F, 64-10, Dongtangiheung-ro, Dongtan-gu, Hwaseong-si, Gyeonggi-do Republic of Korea, Hwaseong-si Gyeonggi, South Korea, 18468
- Owner or operator
- Recensmedical Inc. (10082084)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 15, 2025
- Registered through
- 2027
- Brand names listed
- OcuCool, TargetCool, TargetCool-e
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| QZQ | QZQ | Complaint file establishment, Manufacturer | accessdata.fda.gov | |
| Unit, Cryosurgical, Accessories | GEH | 2 | Manufacturer | accessdata.fda.gov |
| Vapocoolant Device | MLY | U | 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 16, 2025 | K253114 | TargetCool (RM-DT02W) | GEH | Substantially Equivalent | Recensmedical, Inc. | accessdata.fda.gov |
| October 15, 2025 | K253348 | TargetCool-e | GEH | Substantially Equivalent | Recensmedical, Inc. | accessdata.fda.gov |
| September 30, 2024 | DEN230011 | OcuCool | QZQ | Unknown | Recensmedical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 16, 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.