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CDSCO UID IMP/MD/2022/000616_2fc772479ec641bbca0abec946694d6f_e2af5dc07509eca0772bc7cdd058fd53

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_e2af5dc07509eca0772bc7cdd058fd53
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 UltraPulse DUO CO2 laser system is intended for use in surgical applications requiring the ablation, vaporization, excision, incision and coagulation of soft tissue in medical specialties including: • Aesthetic (Lumenis Pulse 100H) • Podiatry • Otolaryngology (Lumenis Pulse 100H) • Gynecology (Lumenis Pulse 100H) • Neurosurgery • Orthopedics (Lumenis Pulse 100H) • General and thoracic surgery (Lumenis Pulse 100H) • Dental and oral surgery • Genitourinary surgery The UltraPulse DUO CO2 system is indicated for use in specific surgical applications, as detailed in this chapter. Read and comprehend all of the following contraindications, warnings, precautions, and recommendations, as well as indications and safety considerations for the 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_e2af5dc07509eca0772bc7cdd058fd53. 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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