Schedule Facility Audit
ISO 13485 Certified Facility

Cleanroom fabrication for clinical energy hardware

Every optical resonator, acoustic transducer, and RF generator is assembled in our Seoul cleanroom under audited K-GMP protocols and rigorous pulse-stability thresholds.

Class 10k

Cleanroom Suite

100%

Oscilloscope Verification

ISO 13485

Audited Standard

Production Workflow

Stepwise cleanroom fabrication

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02
03
04

CNC Chassis Machining

Optical & Acoustic Assembly

Impedance Calibration

Burn-In Load Testing

High-precision milling of medical-grade aluminum assemblies and thermal management chassis.

Cleanroom integration of laser resonators, harmonic lenses, and HIFU piezoceramic transducers.

Precision tuning of RF generator output stages and real-time tissue impedance matching.

Extended thermal and electrical stress testing verified via calibrated oscilloscopes and power meters.

Rigorous Verification

Engineered for regulatory compliance

Traceable serial batch documentation and automated optical power meter verification ensure every finished generator unit meets strict international medical standards before export.

Schedule Facility Audit

Verify our manufacturing standards firsthand

We invite international medical device distributors and regulatory audit teams to conduct remote or in-person inspections of our Seoul cleanroom facilities.