Bioflex LD-R100 Treatment Head
by Meditech International Inc Canada EUDAMED510(k)
510(k) K081355 Product code ILY
Overview
The Bioflex LD-R100 Treatment Head is a Physical Medicine Device designed for low-level laser therapy (LLLT). It delivers therapeutic light energy to promote tissue repair, reduce inflammation, and alleviate pain in musculoskeletal and soft tissue conditions through photobiomodulation principles.
This device is supplied as a reusable component for integration into a larger laser therapy system and requires proper sterilisation between uses. Authorised under FDA 510K and MDD, it is intended for clinical settings where controlled light therapy is administered. The device is classified under product code ILY and must comply with applicable regulatory standards for physical medicine devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK081355 | Date18 Dec 2008 | StatusActive |
| European Union | CE/MDD 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- Withdrawn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
- Meditech International, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Meditech International Inc
Questions
What types of clinical conditions is the Bioflex LD-R100 Treatment Head designed to address, and how does it work?
The Bioflex LD-R100 Treatment Head is designed for low-level laser therapy (LLLT) to promote tissue repair, reduce inflammation, and relieve pain in musculoskeletal and soft tissue conditions. It achieves this through photobiomodulation, delivering therapeutic light energy to targeted areas to stimulate healing and alleviate discomfort.
Is the Bioflex LD-R100 Treatment Head meant for single-use or can it be reused in a clinical setting?
The Bioflex LD-R100 Treatment Head is supplied as a reusable component, intended for integration into a larger laser therapy system. However, it requires proper sterilisation between uses to ensure safety and hygiene in clinical settings.
What regulatory pathways has the Bioflex LD-R100 Treatment Head followed, and what does that mean for its use?
The Bioflex LD-R100 Treatment Head has been authorised under both the FDA 510K pathway in the United States and the MDD (Medical Device Directive) in Europe. This means it has been deemed substantially equivalent to a predicate device in the U.S. and complies with European regulatory standards for physical medicine devices, ensuring its suitability for clinical use in authorised markets.
How is the Bioflex LD-R100 Treatment Head supplied, and what does this imply for its integration into a medical system?
The Bioflex LD-R100 Treatment Head is supplied as a standalone reusable component, meaning it is not a standalone device but rather a modular part designed to be integrated into a larger laser therapy system. This modular design allows clinicians to attach it to compatible systems for delivering low-level laser therapy.
What classification does the Bioflex LD-R100 Treatment Head fall under in regulatory terms, and what does this indicate?
The Bioflex LD-R100 Treatment Head is classified under product code ILY, which categorises it as a physical medicine device. This classification ensures it adheres to regulatory standards specific to devices used for therapeutic interventions like low-level laser therapy, including safety, performance, and clinical effectiveness requirements.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K081355
- EUDAMED