Ophthalmic laser Probe(Laser Probe ) - India CDSCO Medical Device Registration

Ophthalmic laser Probe(Laser Probe ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000280_5d6e0ba49edd067e58b9d9970e61733a_744d77479a5026296ca9cd8bf1dd008c. 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

Ophthalmic laser Probe(Laser Probe )

UID: IMP/MD/2023/000280_5d6e0ba49edd067e58b9d9970e61733a_744d77479a5026296ca9cd8bf1dd008c

Brand Name

PurePoint Laser Photocoagulator

License Holder

Alcon Laboratories (India) Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Alcon laser probes are used for transmission of laser energy to the eye, to reattach the retina, and to remove new vascularization resulting from conditions such as diabetes, macular degeneration and glaucoma. In addition, the laser probes are also used for the following treatments and conditions: Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including: • Proliferative and nonproliferative retinopathy (PurePoint Laser Photocoagulator) • Choroidal neovascularization secondary to age-related macular degeneration • Retinal tears and detachments • Macular edema • Retinopathy of prematurity • Choroidal neovascularization • Leaking micro-aneurysmsIridotomy/ Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (PurePoint Laser Photocoagulator) and Refractory Glaucoma. Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (PurePoint Laser Photocoagulator) and refractory Glaucoma. And other laser treatments including: • Internal sclerostomy • Lattice degeneration • Central and Branch Retinal Vein Occlusion • Suturelysis • Vascular and pigmented skin lesions

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Handpiece

Brand: PurePoint Laser Photocoagulator

Alcon Laboratories (India) Pvt. Ltd.

Ophthalmic laser Probe(Laser Probe ) - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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