A Clinical Evaluation of the Safety and Efficacy of 980 nm Laser with Bare Fiber Tips in the Treatment of ENT Disorders

Modi Darshita Vijaykumar; Pramod Kumar Minocha; Deveshkumar Mahendralal Kothwala; Khusboo Shah; Ovesh Durani; Aakash Thakor

doi:10.63363/aijfr.2025.v06i06.1764

A Clinical Evaluation of the Safety and Efficacy of 980 nm Laser with Bare Fiber Tips in the Treatment of ENT Disorders

Author(s)	Ms. Modi Darshita Vijaykumar, Dr. Pramod Kumar Minocha, Dr. Deveshkumar Mahendralal Kothwala, Khusboo Shah, Ovesh Durani, Aakash Thakor
Country	India
Abstract	In otolaryngologic procedures, improvements in laser technology have significantly increased accuracy, safety, and recuperation time after surgery. The 980 nm diode laser has become well-known among these advancements due to its capacity to be minimally intrusive, its excellent coagulative control, and its decreased intraoperative haemorrhage. It is a flexible choice for a range of soft tissue application because to its small size, adjustable energy settings, and compatibility with common ENT equipment. To evaluate the clinical performance and user safety of the Mesic™ Laser Ablation System (Meril Medical Innovations Pvt. Ltd., Vapi, Gujarat, India) in the minimally invasive management of selected ENT pathologies, in accordance with ISO 13485:2016 and IEC 60825-1 performance and safety standards. This was a prospective, non-randomized clinical study conducted at a tertiary care centre in India with institutional ethical approval. The MesicTM 980nm diode laser system with a bare-tip optical fiber was used to perform laser ablation on three adult patients (ages 28 to 45) who had been diagnosed with ranula, pharyngeal papilloma, and cholesteatoma cyst. The device was purchased with a test certificate conforming the 980nm wavelength specification and a manufacture-validated calibration to guarantee compliance to IEC 60825-1 criteria. Depending on the kind of tissue and the features of the lesion, the laser’s strength varied from 0.4 W to 4 W. The day-care procedures were performed under local or general anaesthesia and included normal postoperative treatment and surveillance at three and six months after the procedure. Clinical outcomes were assessed according to intraoperative visibility, recurrence, bleeding problems, and symptoms relief. All three patients (mean age =36.3±8.5 years) had no intraoperative or postoperative problem, including hematoma of infection, and all their symptoms were completely resolved (100%) after the procedure. A clean operating field and shorter treatment duration were the outcomes of the 980nm diode lasers’ superior hemostasis. Sustained symptoms reduction, no recurrence, and a successful functional and cosmetic recovery were all confirmed by follow-up evaluations conducted three to six months later. The system functioned in full accordance with ISO 13485:2016 quality management and IEC 60825-1 user safety rules. High precision, safety, and therapeutic efficacy were established using the MesicTM 980 nm diode laser during minimally invasive ENT surgery. Its reliability for clinical application is demonstrated by the system’s confirmed wavelength calibration and compliance with international safety and quality standards. These encouraging first findings encourage further through assessment through research involving bigger sample numbers and longer follow-up periods.
Keywords	Keywords: 980 nm Diode Laser; Bare-tip fiber, Minimally Invasive Surgery, Ranula, Pharyngeal Papilloma, Cholesteatoma Cyst, ISO 13485
Field	Biology > Medical / Physiology
Published In	Volume 6, Issue 6, November-December 2025
Published On	2025-11-11
DOI	https://doi.org/10.63363/aijfr.2025.v06i06.1764
Short DOI	https://doi.org/g998rq

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A Clinical Evaluation of the Safety and Efficacy of 980 nm Laser with Bare Fiber Tips in the Treatment of ENT Disorders

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