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CDSCO UID IMP/MD/2022/000616_753f52fe10d3e26c83af61bc624123f4_508b56d3bbcaa6fd958a8b3e87c02c66

CO2 Laser Fiber

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·Device Class Class C·India CDSCO·Brand: Lumenis Pulse 100H
Registration details
UID
IMP/MD/2022/000616_753f52fe10d3e26c83af61bc624123f4_508b56d3bbcaa6fd958a8b3e87c02c66
Device class
Class C
Brand name
Lumenis Pulse 100H
License holder
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
Approving authority
CDSCO
Product information
The OtoLase Flexible CO2 Fiber Delivery System is indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue. Example procedures include stapedotomy or stapedectomy, trans-canal or retro-auricular approaches. This device may be used in the medical specialties or procedures for which the compatible laser has received regulatory clearance
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About this record

CO2 Laser Fiber is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000616_753f52fe10d3e26c83af61bc624123f4_508b56d3bbcaa6fd958a8b3e87c02c66. 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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