BIOPTRON AG

FDA Device Registration & Listing · Neuchatel, CH · Registration 3013929417

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
3013929417
FEI Number
3013929417
Entity Name
BIOPTRON AG
City/State/Country
Neuchatel, CH
Establishment Address
Gouttes d Or 30, Neuchatel 2008, CH
Establishment Type(s)
Manufacture Medical Device
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
3003775404 BIOPTRON AG WOLLERAU Schwyz, CH

Similar Registrations

Registration Number Establishment Name Location
3000985188 ITI Manufacturing Inc. Sugar Land, TX, US
3003775404 BIOPTRON AG WOLLERAU Schwyz, CH
3003725190 MedX Health Corp. MISSISSAUGA Ontario, CA
3035375032 DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA Sao Carlos Sao Paulo, BR
3005730446 MEDICAL QUANT USA Solon, OH, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013929417. Last updated year: 2026. Please use registration number 3013929417 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.