BIOPTRON AG

FDA Device Registration & Listing · WOLLERAU Schwyz, CH · Registration 3003775404

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003775404
FEI Number
3003775404
Entity Name
BIOPTRON AG
City/State/Country
WOLLERAU Schwyz, CH
Establishment Address
SIHLEGGSTRASSE 23, --, WOLLERAU Schwyz CH-8832, CH
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
BIOPTRON AG (Owner Number: 9052406)
Owner / Operator Contact Address
SIHLEGGSTRASSE 23, --, WOLLERAU, CH-NOTA CH-8832, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K032216
PMA Number
N/A

All Registered Proprietary Names

BIOPTRON MedAll BIOPTRON Pro (BPro) Light Therapy System BIOPTRON Compact III (BCIII) Light Therapy System BIOPTRON 2 (B2) Light Therapy System BIOPTRON PRO 1 (BPro1) Light Therapy System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2007-10-08

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: REGULATORY INSIGHT, INC. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

BIOPTRON AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013929417 BIOPTRON AG Neuchatel, CH

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003775404. Last updated year: 2026. Please use registration number 3003775404 when referencing this establishment in official correspondence.
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