Device
The RM STAR EX with RMS Needle is intended for use in dermatologic procedures for electrocoagulation and hemostasis.
Manufacturer
BOMTECH ELECTRONICS CO., LTD.
BOMTECH ELECTRONICS CO., LTD.
Model: Electrosurgical Cutting and Coagulation Device and Accessories
DI: 08800016000436
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
The RM STAR EX with RMS Needle is intended for use in dermatologic procedures for electrocoagulation and hemostasis.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9b4e7e30-8872-475f-950b-506f95506bc6
Distribution Status:
In Commercial Distribution
DUNS Number:
690464958
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08800016000436
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44680
Name: Electrosurgical handpiece, reusable
Definition:
A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a reusable device.
FDA Product Codes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
Premarket Submissions
Submission Number:
K243097
Supplement Number:
000