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Holmium Laser System - India CDSCO Medical Device Registration

Holmium Laser System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000616_756597f72f9868675fc270f84739f312_7575b028579c727a2d4987355d56a74b. This device is marketed under the brand name Lumenis Pulse 100H. The license holder is Boston Scientific India Private Limited ,C/o Parekh Integrated Services Pvt.Ltd., 1st Floor, Khasra Nos. 9//12/3 min (3-17), 13/3min (5-7), 18(8-0), 19min (5-16), 22min (5-16), 23(8-0), 13//2min (5-16), 3 (8-0), Village Bhangrola, Sector M-12 ,Gurgaon Haryana ,122505 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Holmium Laser System
UID: IMP/MD/2022/000616_756597f72f9868675fc270f84739f312_7575b028579c727a2d4987355d56a74b

Brand Name

Lumenis Pulse 100H

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Lumenis Pulse 120H System with Delivery Devices and Accessories are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery.

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