Development, production and distribution of low-level laser therapy devices for hospitals and practices
Heltschl GmbH Medizintechnik
Hoheneckstraße 9, A-4713 Gallspach, AustriaNew on Amplifa
About Heltschl Medizintechnik
Heltschl GmbH Medizintechnik has been active in the field of low-level laser therapy since 1994 and develops, produces and distributes therapeutic laser devices in Austria and neighbouring countries. The portfolio includes portable, battery-operated therapy lasers (HILARIS® TL), mains-operated area lasers (HILARIS® FL RED/BLUE) and systems for intravenous laser blood irradiation (HILARIS® HAEMO RED/BLUE). The devices are used for pain therapy, for wound healing disorders, sports injuries and for acupuncture. In addition to its own production, the company offers service, repair and the recurring safety inspection (STK) of laser devices from all manufacturers according to EN 62353 in its own test laboratory, whose measuring system is externally calibrated. The company is also the exclusive authorised sales and service partner for hawo film welding devices in Austria. Customers include university hospitals in Austria, Germany and Switzerland as well as numerous international clinics and practices. Since the end of 2022, the company has been based at Hoheneckstraße 9 in Gallspach, Upper Austria.
- Site
- A-4713 Gallspach
- Processes
- Repair, metrological and safety inspection (STK according to EN 62353) of laser devices, Performance control and verification of therapeutic laser devices incl. test report, Development, production and distribution of low-level laser therapy devices (portable, On-site maintenance of laser devices, Distribution, service and repair of hawo film welding devices incl. validation (packaging, Development, production and distribution of low-level laser therapy devices, Service and maintenance of laser devices from all manufacturers, Repair and safety inspection (STK) in accordance with EN 62353 with test laboratory and test reports
- Certificates
- EN ISO 13485, EU Directive 93/42/EEC, STK inspection according to EN 62353
- Founded
- 1994
- Industries
- Medical technology, Hospitals, Medical practices, Naturopathic practice/alternative practitioners, Packaging technology (hawo film welding devices)
- 01
Research and development (in cooperation with universities)
- 02
Production of laser therapy devices
- 03
Distribution
- 04
Seminars and training
- 05
Service, maintenance, STK inspection (EN 62353)
Location
Gallspach
ATHead office since the end of 2022: development, production, distribution, service and test laboratory
- Test laboratory for laser power measurement (externally calibrated measuring system)
Laser Devices
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Repair, metrological and safety inspection (STK according to EN 62353) of laser devicesTesting | – | – | – | – | – |
| Performance control and verification of therapeutic laser devices incl. test reportTesting | – | – | – | – | – |
| Development, production and distribution of low-level laser therapy devices (portableAssembly | – | – | – | – | – |
| On-site maintenance of laser devicesTesting | – | – | – | – | – |
| Distribution, service and repair of hawo film welding devices incl. validation (packagingAssembly | – | – | – | – | – |
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Test laboratory for laser power measurement (measuring system, externally calibrated) | – | – | – | – | Gallspach, Austria |
Additional services
Reference customers
Quality and QM System
Production takes place according to a certified quality management system in accordance with EN ISO 13485 and EU Directive 93/42/EEC with constant checks during the production processes and an annual audit by the notified body. In the test laboratory, laser devices from all manufacturers undergo a fully documented inspection (STK according to EN 62353) including a test report.
| Evidence | Gallspach |
|---|---|
| EN ISO 13485 | |
| EU Directive 93/42/EEC | |
| STK inspection according to EN 62353 |
History
- 1994
Foundation and start of activities in the field of low-level laser therapy
- 2022
Relocation of the company headquarters to Hoheneckstraße 9, A-4713 Gallspach