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CO2 Laser System - India CDSCO Medical Device Registration

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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CDSCO Registered
Class Class C
CO2 Laser System
UID: IMP/MD/2022/000616_2fc772479ec641bbca0abec946694d6f_e2af5dc07509eca0772bc7cdd058fd53

Brand Name

Lumenis Pulse 100H

Device Class

Class C

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: โ€ข Aesthetic (Lumenis Pulse 100H) โ€ข Podiatry โ€ข Otolaryngology (Lumenis Pulse 100H) โ€ข Gynecology (Lumenis Pulse 100H) โ€ข Neurosurgery โ€ข Orthopedics (Lumenis Pulse 100H) โ€ข General and thoracic surgery (Lumenis Pulse 100H) โ€ข Dental and oral surgery โ€ข 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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