LD-I 75 and LD-I 200
by Meditech International Inc Canada EUDAMED510(k)
510(k) K072551 Product code NHN
Overview
The LD-I 75 and LD-I 200 are powered light-based laser instruments designed for non-thermal adjunctive use in pain therapy. Classified as a non-heating laser device under FDA regulation 890.5500, they emit light to complement traditional pain management techniques without generating thermal effects.
These devices are supplied as reusable medical instruments and are regulated under FDA 510(k) clearance (K072551) and the European Medical Device Directive (MDD). They are intended for use in clinical settings by trained professionals, adhering to Class II standards for safety and performance. No specific sterility or MRI safety information is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK072551 | Date2 Apr 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- Withdrawn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
- NHN
- 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 is the primary purpose of the LD-I 75 and LD-I 200 laser devices in pain management?
The LD-I 75 and LD-I 200 are designed as non-thermal laser instruments to provide adjunctive support in pain therapy. They emit light to complement traditional pain management techniques without producing heat, making them suitable for use alongside other clinical interventions in controlled settings.
Are the LD-I 75 and LD-I 200 devices single-use or reusable, and what does that mean for maintenance?
These devices are reusable medical instruments, meaning they are intended for repeated use after proper cleaning and maintenance. Since they are not sterile by default, clinical staff must follow established protocols for reprocessing to ensure safety and performance between uses.
What regulatory pathways have the LD-I 75 and LD-I 200 followed in the U.S. and Europe?
In the U.S., the devices received FDA 510(k) clearance (K072551) under the Physical Medicine advisory committee, classified as substantially equivalent to prior devices. In Europe, they comply with the European Medical Device Directive (MDD), adhering to Class II safety and performance standards.
How do I determine which model (LD-I 75 or LD-I 200) is appropriate for my clinical needs?
The distinction between the LD-I 75 and LD-I 200 is based on their output specifications (not explicitly detailed here, but implied by the model numbers). The LD-I 75 likely refers to a lower-power configuration, while the LD-I 200 suggests a higher-power variant. Consult the manufacturer’s technical documentation or a specialist to match the device’s power output to your specific pain management protocols.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K072551
- EUDAMED