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CDSCO UID IMP/MD/2022/000616_2fc772479ec641bbca0abec946694d6f_f79194422b7a89fc8c6db84e19cd6788

CO2 Laser System

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_2fc772479ec641bbca0abec946694d6f_f79194422b7a89fc8c6db84e19cd6788
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 intended use of the AcuPulse DUO system is for the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the surgical specialties of: ? Podiatry ? ENT ? Gynecology ? Laparoscopic Surgery including GYN Laparoscopy. ? Dental and Oral Surgery. ? Neurosurgery ? Orthopedics ? General Surgery. The carbon dioxide laser wavelength is indicated for use in specific surgical applications, as detailed in this chapter. Read and comprehend all of the following general contraindications, warnings, precautions, and recommendations, as well as indications and safety considerations for appropriate specialties
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About this record

CO2 Laser System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000616_2fc772479ec641bbca0abec946694d6f_f79194422b7a89fc8c6db84e19cd6788. 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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