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Femtosecond ophthalmic solid-state laser system - India CDSCO Medical Device Registration

Femtosecond ophthalmic solid-state laser system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000280_7a275a19f7f268f1c76ba449df7f5e8e_a8d368a82f2849943410e28e6eb09328. This device is marketed under the brand name PurePoint Laser Photocoagulator. The license holder is Alcon Laboratories (India) Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Femtosecond ophthalmic solid-state laser system
UID: IMP/MD/2023/000280_7a275a19f7f268f1c76ba449df7f5e8e_a8d368a82f2849943410e28e6eb09328

Brand Name

PurePoint Laser Photocoagulator

Device Class

Class C

Approving Authority

CDSCO

Product Information

The LenSx Laser System is indicated for use: โ€ข In the creation of corneal cuts/incisions (PurePoint Laser Photocoagulator), anterior capsulotomy and laser photofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery. โ€ข In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. โ€ข In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings

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