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Holmium Laser Fiber - India CDSCO Medical Device Registration

Holmium Laser Fiber is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000616_f549e07bca8acbce38761dedd9dd1fb8_99a141fb4a4814d062ff2a1ac07402e7. 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 Fiber
UID: IMP/MD/2022/000616_f549e07bca8acbce38761dedd9dd1fb8_99a141fb4a4814d062ff2a1ac07402e7

Brand Name

Lumenis Pulse 100H

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Xpeeda D/S/L fiber is intended for use with the compatible lasers in surgical procedures involving open, laparoscopic, endoscopic ablation, vaporization, excision, incision and coagulation of soft tissue. For the safe use of the fiber read and comprehend these instructions and the appropriate laser operator manual before use

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