Model: VeinCure
DI: 06978556800006
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4430df46-b494-4e81-b150-bce111f315a8
Distribution Status:
In Commercial Distribution
DUNS Number:
622798913
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:
06978556800006
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60341
Name: General/multiple surgical diode laser system
Definition:
An electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.
FDA Product Codes
GEX
Powered Laser Surgical Instrument
Premarket Submissions
Submission Number:
K252564
Supplement Number:
000