RM STAR EX with RMS Needle
by Bomtech Electronics Co., Ltd. EUDAMED510(k)
Active
510(k) K243097
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK243097 | Date26 Dec 2024 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The RM STAR EX with RMS Needle is a radiofrequency-based dermatologic device (General, Plastic Surgery) designed for electrocoagulation and hemostasis in skin procedures. It employs controlled radiofrequency energy to achieve precise tissue effects, including coagulation and sealing of small blood vessels or lesions.
This device is intended for single-use in dermatologic settings and is sterile upon packaging. Supplied as a reusable instrument with disposable RMS Needle attachments, it adheres to FDA 510(k) clearance (K243097) and MDD compliance. No MRI safety classification or reusable sterilization instructions are specified in the data.
Other devices from Bomtech Electronics Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
What types of skin procedures is the RM STAR EX with RMS Needle designed to assist with specifically?
The RM STAR EX with RMS Needle is designed for electrocoagulation and hemostasis in dermatologic procedures, particularly for sealing small blood vessels or lesions. Its controlled radiofrequency energy allows for precise tissue effects, making it useful for procedures where minimizing bleeding and achieving targeted coagulation are important.
Is the RM STAR EX with RMS Needle meant to be used repeatedly, or is it single-use?
The RM STAR EX itself is a reusable instrument, while the RMS Needle attachments are intended for single-use. This design ensures sterility for each procedure, as the needles are sterile upon packaging, reducing the risk of cross-contamination.
How is the device supplied, and what should I check before using it?
The RM STAR EX with RMS Needle is supplied as a reusable base unit with disposable RMS Needle attachments. Before use, verify that the RMS Needle is intact and sterile (as it is packaged sterile), and ensure the reusable instrument is clean and free of damage. No specific reusable sterilization instructions are provided, so follow manufacturer guidelines for maintenance.
Are there different sizes or models of the RMS Needle available, and how do I choose the right one?
The specifications provided do not detail specific sizes or models of the RMS Needle, so you would need to consult the manufacturer’s documentation or support for guidance on selecting the appropriate needle for your procedure. The device’s design suggests compatibility with disposable attachments, so compatibility should be confirmed before use.
How should I store the RM STAR EX with RMS Needle when not in use?
Since the RMS Needle attachments are single-use and sterile upon packaging, they should be stored according to the manufacturer’s instructions for sterile disposable items—typically in a clean, dry environment away from direct sunlight or extreme temperatures. The reusable RM STAR EX base unit should be stored in a clean, dry place, following Bomtech Electronics’ maintenance guidelines to preserve its functionality.