DioBeam 830
510(k) K031499
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK031499 | Date16 Sep 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NHN
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The DioBeam 830 is a Powered Light-Based Laser Non-Thermal Instrument classified under 21 CFR 890.5500 as a lamp, non-heating, for adjunctive use in pain therapy. This device emits non-thermal light to provide adjunctive support in pain management procedures, operating without generating heat to avoid thermal tissue effects.
Intended for use in physical medicine settings, the DioBeam 830 is a Class II medical device cleared under FDA 510(k) (K031499). Supplied as a reusable instrument, it adheres to regulatory standards for adjunctive pain therapy applications. No specific sterility or MRI safety information is provided in the submitted data.
Other devices from Soft-Core Texas, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the DioBeam 830 in clinical settings and how does it differ from traditional thermal treatments?
The DioBeam 830 is a non-thermal laser device designed as an adjunctive tool in pain management procedures within physical medicine settings. Unlike traditional thermal treatments, it emits light without generating heat, avoiding potential thermal tissue effects while providing supportive pain therapy. This makes it suitable for scenarios where heat-sensitive tissues or conditions require a gentler approach.
Is the DioBeam 830 intended for single-use or reusable applications, and what does this mean for maintenance?
The DioBeam 830 is supplied as a reusable instrument, meaning it is designed for repeated use in clinical settings. This implies that proper cleaning, disinfection, and maintenance protocols must be followed to ensure safety, sterility, and optimal performance between uses. The manufacturer’s instructions should be consulted for specific guidelines.
What regulatory pathway was followed for the approval of the DioBeam 830, and what does this classification mean for its use?
The DioBeam 830 was cleared through the FDA’s 510(k) pathway under the classification of a Class II medical device (product code NHN), specifically as a powered light-based laser instrument for adjunctive use in pain therapy. This classification indicates it has been deemed substantially equivalent to a legally marketed device and is regulated under 21 CFR 890.5500 for non-heating lamp applications in physical medicine.
Are there any specific storage requirements or considerations for the DioBeam 830?
The provided data does not specify any unique storage requirements for the DioBeam 830 beyond standard guidelines for reusable medical devices. However, to maintain functionality and hygiene, it should be stored in a clean, dry environment, protected from physical damage, and kept away from direct sunlight or extreme temperatures. Always refer to the manufacturer’s instructions for detailed storage recommendations.