Cleft lips and cleft palates are the most common birth defects in newborns. Pre-surgical correction of unilateral and bilateral cleft lips and palates has been the subject of interest of many previous works. This condition has necessitated the evolution of many surgical and non-surgical techniques to mitigate the problem of this deformity in children. In this study, we proposed a new architecture that can be used instead of the conventional pre-surgical treatment. The proposed architecture has mechanical and electronic parts. This architecture was adopted to apply external stress to the cleft bones and cleft edges using an airbag that is located in the mechanical part. The amount of air in the airbag can be controlled by an available control unit in the electronic part. The effect of external stress on the cleft bones and the cleft edges was analyzed by using the finite element analysis (FEA) method. The FEA study aimed to analyze the displacement, amount of tensile and compressive forces, and Von Mises stress distributions on the cleft bones, cleft edges, nasal septum, and superior alveolar part of the maxillary jaw of unilateral and bilateral cleft models during pre-surgical treatment with the novel architecture. The results show that displacement and stress affected the clefts of both models. Displacement had a significant effect of gradually bringing the clefts closer to each other and returning them to the posterior. The analysis also investigated the effects of stress on the cleft bone and cleft edge. It was found from the results that the stresses helped to bring the incisions closer to the most appropriate position for plastic surgeons. The results prove that the positive and negative X-displacements move in the opposite direction, which means that the cleft edges gradually converge toward each other. Moreover, the negative Z-displacement affected the movement of cleft bones and cleft edges from outside to inside and gradually returned them to a suitable position. The findings show that the proposed architecture can be contributed to the pre-surgical treatment of the unilateral and bilateral clefts as an alternative to the traditional method.