
Medical Device

CE Mark (Europe)

UKCA Mark for UK

Authorized Representative in the European Community
PRODUCT DESCRIPTION
Younger Mfg. Co. dba Younger Optics manufacture ophthalmic lenses. These lenses are made up of a variety of materials, treatments and designs. The materials used are from a variety of different plastics manufactured and tested according to applicable regulatory requirements.
INDICATIONS FOR USE
The Younger Optics semi-finished lenses are indicated for use, after further laboratory processing, to assist with correcting vision associated with nearsightedness, farsightedness, astigmatism and presbyopia. They are intended to be used by patients under the direction and prescription of an eye care practitioner i.e. optometrist.
DIRECTIONS FOR USE
Younger Optics Semi-Finished Lenses are sold to qualified ophthalmic laboratories for further processing which includes surfacing, grinding, polishing, coating, etc. Each lab should follow their own internal procedures and protocols for adequately processing semi-finished lenses accordingly and in a qualified manner.
WARNINGS AND PRECAUTIONS
The Younger Optics Sem-finished devices are not considered finished medical devices and are therefore not intended for use until after they have been further processed by a qualified laboratory. They are not intended to be used by patients or end users until after further product finishing, processing, and being inserted into glasses / frames upon the prescription of an eye care practitioner.
For further information or to request a physical copy of these instructions for use, please contact Younger Optics.