Data / Medical devices / United States / Cure Point Therapeutics, Inc
Cure Point Therapeutics, Inc: FDA-registered device maker in Santa Monica, CA, United States, 1 510(k) clearance
Cure Point Therapeutics, Inc is registered with the FDA (registration 3033274371) in Santa Monica, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 15, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033274371
- Address
- 1821 Wilshire Blvd Ste 300, Santa Monica, CA, United States, 90403
- Owner or operator
- Cure Point Therapeutics, Inc (10091897)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 14, 2024
- Registered through
- 2026
- Brand names listed
- SIRONA 100 (aka EVANLAS) Therapy Laser System, SIRONA 100 (aka EVANLAS) Therapy Laser System - Podiatry
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Specification developer | 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 15, 2024 | K231997 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | ILY | Substantially Equivalent | Cure Point Therapeutics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 15, 2024. 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.