Data / Medical devices / Switzerland / Bioptron AG
Bioptron AG: FDA-registered device maker in WOLLERAU Schwyz, Switzerland, 1 510(k) clearance
Bioptron AG is registered with the FDA (registration 3003775404) in WOLLERAU Schwyz, Switzerland. It lists 2 device types. 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.
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
- 3003775404
- Address
- Sihleggstrasse 23 --, WOLLERAU Schwyz, Switzerland, CH-8832
- Owner or operator
- BIOPTRON AG (9052406)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- 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, PZFG-TYT120 TESLA HYPERLIGHT EYEWEAR, SILHOUETTE, MODEL 120, THE-0101BG TESLA HYPERLIGHT EYEWEAR, MODEL 5355, BEIGE, THE-0101BN TESLA HYPERLIGHT EYEWEAR, MODEL 5355, BROWN and more
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 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | 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
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
- All makers of Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
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.