Laserpen Practise and Expert, Handylaser Sprint, Handylaser Trion, Physiolaser Olympic, Polylaser
by Reimers & Janssen GmbH EUDAMED510(k)
Active
510(k) K091675
Overview
These devices are low-level laser therapy (LLLT) devices designed for soft tissue stimulation, pain relief, and wound healing. They emit specific wavelengths of light to promote cellular repair, reduce inflammation, and enhance tissue regeneration in musculoskeletal and dermatological applications.
The devices are single-use or reusable (depending on model) and intended for use in clinical, physiotherapy, and home settings. They comply with FDA 510(k) clearance and MDR, with models including Handylaser Sprint, Handylaser Trion, Physiolaser Olympic, Polylaser, and Laserpen Practise and Expert. No MRI safety or sterility specifications are provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK091675 | Date15 Dec 2009 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- ILY
- FDA applicant
- Reimers and Janssen GmbH
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Reimers & Janssen GmbH
Questions
What are the primary clinical applications for these laser therapy devices in musculoskeletal and dermatological treatments?
These devices are designed for soft tissue stimulation, pain relief, and wound healing using low-level laser therapy (LLLT). They target cellular repair, reduce inflammation, and promote tissue regeneration in musculoskeletal conditions (e.g., joint or muscle pain) and dermatological applications (e.g., minor wounds or skin healing). The specific wavelengths of emitted light are intended to support these processes without invasive procedures.
Are these devices meant for single-use or can they be reused, and how does that vary by model?
The devices vary by model: some are single-use, while others are reusable. The data does not specify which models fall into each category, so users should refer to the manufacturer’s instructions for the specific model (e.g., Laserpen Practise and Expert vs. Handylaser Sprint) to confirm usage guidelines. Reusability may depend on design features like disposable tips or cleaning protocols.
Can these devices be used at home by patients, or are they strictly for clinical or physiotherapy settings?
The devices are intended for use in clinical, physiotherapy, and home settings, according to the manufacturer. However, proper training and adherence to instructions are critical for safe and effective use, especially in home environments. Always follow the manufacturer’s guidelines to ensure correct application and avoid misuse.
What regulatory pathways have these devices undergone, and which committee reviewed their submission?
These devices have undergone FDA 510(k) clearance and comply with the EU Medical Device Regulation (MDR). The submission was reviewed by the Physical Medicine (PM) Advisory Committee under the product code ILY, with a decision dated December 15, 2009, confirming substantial equivalence to predicate devices. The regulatory route ensures compliance with safety and performance standards for low-level laser therapy applications.
How should I determine which model is best suited for my practice or patient needs?
The selection depends on your specific clinical or home-use requirements. The manufacturer offers multiple models (e.g., Handylaser Sprint, Physiolaser Olympic, Laserpen Practise and Expert) with varying features like single-use/reusability and possibly different power outputs or probe designs. Consult the manufacturer’s documentation or contact Reimers & Janssen GmbH (contact: Astrid Schulze) for guidance on matching a model to your intended applications, such as portability, treatment area coverage, or patient comfort.