Data / Medical devices / Switzerland / Bioptron AG
Bioptron AG: FDA-registered device maker in Neuchatel, Switzerland, 1 510(k) clearance
Bioptron AG is registered with the FDA (registration 3013929417) in Neuchatel, Switzerland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 4, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013929417
- Address
- Gouttes d Or 30, Neuchatel, Switzerland, 2008
- Owner or operator
- BIOPTRON AG (9052406)
- Roles
- Manufacturer
- First device listed
- October 8, 2007
- Registered through
- 2026
- Brand names listed
- BIOPTRON 2 (B2) Light Therapy System, BIOPTRON Compact III (BCIII) Light Therapy System, BIOPTRON MedAll, BIOPTRON PRO 1 (BPro1) Light Therapy System, BIOPTRON Pro (BPro) Light Therapy System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | NHN | 2 | 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 |
|---|---|---|---|---|---|---|
| February 4, 2004 | K032216 | BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM | NHN | Substantially Equivalent | Bioptron AG | accessdata.fda.gov |
Compare with other makers
Updated February 4, 2004. 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.