NMA 1052 Console System With NMA 100 Laser Accessory
510(k) K024310
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK024310 | Date24 Mar 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- Withdrawn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, 23 Sep 2026
The device is a Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy, as defined in the openFDA data. It is a console system that includes the NMA 1052 console and the NMA 100 laser accessory, designed for use in pain therapy applications.
It is supplied as a reusable system intended for use in clinical settings, with authorization under FDA 510(k) clearance (K024310). The device is classified as Class II and is indicated for adjunctive use in pain therapy, with no claims of sterility, single-use status, MRI safety, or specific storage conditions provided in the data.
Other devices from Medx Electronics, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the NMA 1052 console system with NMA 100 laser accessory used for?
The device is indicated for adjunctive use in pain therapy as a powered light-based laser non-thermal instrument with non-heating effect, meaning it delivers laser energy without generating significant heat to support pain management in clinical settings.
Is the NMA 1052 console system with NMA 100 laser accessory sterile or single-use?
The device is supplied as a reusable system and does not make any claims of sterility or single-use status; it is intended for repeated use in clinical environments after appropriate cleaning and maintenance per manufacturer guidelines.
What regulatory clearance does the NMA 1052 console system with NMA 100 laser accessory have?
The device has received FDA 510(k) clearance under submission number K024310, classified as Class II, and was determined to be substantially equivalent to a predicate device; this clearance is based on traditional review pathways.