Modification to Thermacool Tc System

K032088 is the FDA 510(k) clearance record for MODIFICATION TO THERMACOOL TC SYSTEM, a class II device, cleared for Thermage, Inc. on 2003-08-01 under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 37 510(k) clearances for Solta Medical, Inc., from 1999-08-12 to 2024-08-21. As of 2026-09-10, FDA records show no recalls naming K032088.