FDA Registration
Active
🇨🇭 Switzerland
BIOPTRON MedAll
Reg #: 3013929417
·
FEI: 3013929417
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOPTRON AG
- Registration Number
- 3013929417
- FEI Number
- 3013929417
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gouttes d Or 30
- City
- Neuchatel
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K032216
Owner / Operator
- Firm Name
- BIOPTRON AG
- Operator Number
- 9052406
- Address
- SIHLEGGSTRASSE 23, --
- City
- WOLLERAU
- State
- CH-NOTA
- Postal Code
- CH-8832
- Country
- CH
US Agent
- Business Name
- REGULATORY INSIGHT, INC.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | NHN | Class 2 | Physical Medicine | No | 2007-10-08 |
Proprietary Names
BIOPTRON MedAll
BIOPTRON 2 (B2) Light Therapy System
BIOPTRON Pro (BPro) Light Therapy System
BIOPTRON PRO 1 (BPro1) Light Therapy System
BIOPTRON Compact III (BCIII) Light Therapy System
Establishment Types
Manufacture Medical Device