FDA Clears CellFX System for the Treatment of Sebaceous Hyperplasia

The US Food and Drug Administration (FDA) has cleared Pulse Biosciences’ CellFX System, powered by Nano-Pulse Stimulation, for the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III.¹The FDA’s clearance was based on Pulse Biosciences’ Investigational Device Exemption (IDE) approved study for the treatment of sebaceous hyperplasia.

This specific indication clearance improves the CellFX System’s general indication FDA clearance and enables Pulse Biosciences to support clinics in promoting CellFX treatments specifically for patients with sebaceous hyperplasia.

Pulse Biosciences also recently received FDA 510(k) clearance of 2 additional treatment tips with larger spot sizes, specifically 7.5mm and 10mm tip sizes, for treating larger benign lesions. These treatment tips expand their portfolio of previously available 1.5mm, 2.5mm, and 5.0mm treatment tip sizes.

The CellFX System targets benign lesions using Nano-Pule Stimulation. CellFX does not destroy the healthy, non-cellular collagen foundation that surrounds lesions. Pulse Biosciences’ technology reduces the risks of unnecessary damage or scarring.

Sebaceous hyperplasia is a common, benign condition of sebaceous glands in adults of middle age or older, caused by the overproduction of sebaceous oil.² Lesions can be single or multiple and manifest as yellowish, soft, small papules on the face, especially the nose, cheek, and forehead. Rarely reported variants have included a giant form, a linear or zosteriform arrangement, a diffuse form, a nevoid form, and a familial form. Lesions of sebaceous hyperplasia are benign, with no known potential for malignant transformation, but they may be associated with nonmelanoma skin cancer in transplantation patients.

Common facial papules appear in middle age, are larger than lesions on the areola or mouth, and display a central dell that corresponds to a central follicular infundibular ostium. Sebaceous hyperplasia is benign and doesn’t pose any serious health risks, but if the spots last too long, they may have a similar appearance to basal cell carcinoma.

References:

1. Pulse biosciences announces FDA 510(K) clearance for the treatment of sebaceous hyperplasia. Published September 26, 2022. Accessed September 27, 2022. https://www.businesswire.com/news/home/20220926005228/en/Pulse-Biosciences-Announces-FDA-510-k-Clearance-for-the-Treatment-of-Sebaceous-Hyperplasia
2. Sebaceous hyperplasia: background, pathophysiology, etiology. Published online May 18, 2021. Accessed September 27, 2022. https://emedicine.medscape.com/article/1059368-overview#:~:text=Sebaceous%20hyperplasia%20is%20a%20common,%2C%20cheeks%2C%20and%20forehead).