Fotona TimeWalker laser line systems - HSA Registration DE0508406
Access comprehensive regulatory information for Fotona TimeWalker laser line systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508406 and owned by Fotona d.o.o. The device was registered on August 18, 2023.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Er:YAG Laser: • Indications in Gynecology: - Herpes simplex - Endometrial adhesion - CIN (Cervical Intraepithelial Neoplasia) - Cysts - Condyloma - Manage Symptoms of Stress Urinary Incontinence (SUI) - Vulvovaginal atrophy (VVA) / Genitourinary Syndrome of Menopause (GSM) • Genitourinary Indications: - Lesions of the external genitalia, urethra, anus, penis, scrotum, and vulvar lesions (including genital warts and intraepithelial neoplasia) • General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, tissue ablation and vessel coagulation is necessary. Nd:YAG Laser: • General Surgery: Surgical incision, excision, vaporization and coagulation of soft tissue. All soft tissue is included: striated and smooth tissue, muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands.