BRITZMEDI Intellectual Property — Core Patents & Regulatory Certifications
A handpiece device that maximizes skin beautification without burn risk through a triple mechanism: RF electricity + eccentric rotation (rubbing) + vibration (tapping).
Controls deep heat penetration depth by changing bipolar electrode pair positions — providing both skin beautification mode (shallow dermis) and body fat reduction mode (deep dermis) in a single device.
FDA 510(k) clearance letter confirming MTX-C1 is substantially equivalent to predicate device Venus Legacy CX (K143554). Includes indications for use, device description, and performance data.
FDA establishment registration confirming BRITZMEDI CO., LTD as a registered facility (No. 3029916132) with ToRR device listing under product code GEI, Class 2.
Official FDA 510(k) premarket notification database record for MTX-C1. Confirms device classification, review panel assignment, and substantially equivalent decision.