Breaking News! Tianchen (Tianjin) Biotech Co., Ltd. has officially secured Class III Medical Device Registration Certificate for its Ophthalmic Intense Pulsed Light (IPL) Therapeutic Device.

Tianchen (Tianjin) Biotech Co., Ltd. has officially secured Class III Medical Device Registration Certificate for its Ophthalmic Intense Pulsed Light (IPL) Therapeutic Device.

Tianchen (Tianjin) Biotech Co., Ltd. (Tianchen Biotech) has achieved a milestone with its Class III Medical Device Registration Certificate (issued by China NMPA on Dec 23, 2024) for the selfdeveloped Ophthalmic Intense Pulsed Light (IPL) Therapeutic Device (Model: TC.DED.Ⅱ). This breakthrough marks a major advancement in ophthalmic medical technology and promises new hope for dry eye patients.

With the change of modern lifestyle and the popularity of electronic products, the incidence rate of dry eye is increasing year by year. The Consensus of Clinical Diagnosis and Treatment Experts for Dry Eye in China (2024) states that "according to the existing epidemiological research results in China, the incidence of dry eye is about 21.0% to 52.4%". Dry eye syndrome not only affects the quality of life of patients, but may also lead to serious consequences such as visual impairment. Therefore, the market demand for the treatment of dry eye syndrome is huge and continues to grow.

In February 2022, the "Dry Eye Rehabilitation Professional Group of the Visual Rehabilitation Committee of the Chinese Rehabilitation Medicine Association" released the "Expert Consensus on the Treatment of Meibomian Adenoid Dysfunction and Related Dry Eyes with Intense Pulsed Light (2022)". Intense pulsed light (IPL) therapy is one of the new physical therapies for treating meibomian gland dysfunction (MGD) and MGD related dry eye in clinical practice, which has received widespread attention from clinical doctors. The expert consensus group on the clinical application of dry eye intense pulsed light has developed this consensus based on extensive investigation, research, and careful discussion of the standardized operation process of IPL in ophthalmology, according to its application progress and principle of action. It provides recommendations for the standardized clinical application of IPL and also provides a basis for the standardization of the diagnosis and treatment mode of dry eye diagnosis and treatment centers in China.

In December 2024, the Ophthalmology Branch of the Chinese Medical Association and the Corneal Disease Group of the Ophthalmology Branch of the Chinese Medical Association jointly released the latest "Expert Consensus on Clinical Diagnosis and Treatment of Dry Eye in China (2024)". This revision is based on the latest clinical research results and experience, summarizing and condensing clinical viewpoints and understanding, revising and updating expert consensus, and meeting the needs of clinical practice.

Article 7 of the "Consensus of Clinical Diagnosis and Treatment Experts for Dry Eye in China (2024)" clearly states that(4) Non pharmacological Treatment" in "Treatment of Dry Eye" clearly states that "IPL treatment: the use of IPL photothermal and photochemical effects generated by incoherent multispectral light to treat MGD, blepharitis, and demodex infection can significantly improve TBUT, tear secretion function, blepharoplasty edema, and eyelid lipid viscosity of dry eye, and has mite removal effect. Treat 3 or 4 times in one course, with a treatment interval of 2-3 weeks, and increase the course of treatment.

The approved product this time is the Ophthalmic Intense Pulse Light Therapy Device (Model: TC.DED.II), which is one of the few Class III medical devices approved by the National Medical Products Administration in China for the treatment of dry eye related to meibomian gland dysfunction.

The ophthalmic intense pulsed light therapy instrument (model: TC.DED.Ⅱ) uses multi wavelength pulsed light, with the range of 590_1200nm visible light to nearinfrared light as the main treatment basis, and designs the size of the treatment head and the combination of pulse parameters according to the clinical ophthalmic needs, so as to build a dry eye intense pulsed light therapy device more suitable for countrymen characteristics.

The mechanism of action of IPL and its MGD related dry eye

Leveraging advanced optical and pulsed light therapy, this device applies multi.wavelength pulsed light to the ocular area, effectively improving meibomian gland function and enhancing tear secretion to alleviate dry eye symptoms. With advantages of non-invasiveness, minimal trauma, and rapid recovery, it is gaining broad recognition among clinicians and patients.

Tianchen (Tianjin) Biotechnology Co., Ltd. was established in 2018 and is headquartered in Tianjin. It is a professional company engaged in the research and development, production, and sales of ophthalmic medical devices. The company has multidisciplinary teams in materials science, optics, ophthalmology, and clinical practice, dedicated to developing hightech barrier medical devices that do not meet clinical needs in ophthalmology. Our company's products are designed to provide safe and effective ophthalmic treatment equipment and implant consumables for patients with eye diseases such as dry eye syndrome, glaucoma, and refractive errors, providing a complete diagnosis and treatment solution for medical care.

The company has a research and development center and production center in Tianjin, a passive consumables research and development and production sub center in Suzhou, and a sales center in Nantong. With strong research and development capabilities and resource integration capabilities, the company has established deep cooperative relationships with many well-known hospitals and universities at home and abroad, jointly promoting the innovation and development of ophthalmic medical devices.

Tianchen (Tianjin) Biotechnology Co., Ltd. adheres to the concept of "technology leads health" and is committed to providing safer, more effective, and convenient medical equipment products and services for ophthalmic patients.