DEVICE DETAILS
NAME OF DEVICE | SOFT CONTACT LENS |
---|---|
ESTABLISHMENT NAME | SOLAVISH SDN. BHD. |
ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
REGISTRATION NO | GB4596723-139096 |
BRAND NAME | IVY LENSE |
MEDICAL DEVICE CATEGORY | MD 0105 - Non-active ophthalmologic devices |
DEVICE GROUPING TYPE | FAMILY |
DEVICE DESCRIPTION | Soft Contact Lens is a coloured contact lens with 57 varieties of colours intended for cosmetic purpose to enhance and change the hue of eyes of the wearer. It is meant for short-term contact and reusable. Soft Contact Lens is indicated for adults for cosmetic effects. Soft Contact Lens comes in package containing preservation solutions of boric acid and sodium chloride salt solutions. Soft Contact Lents is a sterile product. The lens is designed to be attached to the corneal tear layer and the lens is slightly covered by the eyelid. When blinking, the eyelid slides on the surface of the lens, causing the lens to move slightly. The tears provide the necessary lubrication for the cornea and help to expel foreign matter. |
DEVICE INTENDED PURPOSE | Intended for cosmetic purpose to enhanced and change the hue of the eyes of the wearer. |
VALIDITY DATE OF REGISTRATION | 08/07/2023 - 07/07/2028 |