| Device |
prescription spectacle lenses to reduce the progression of myopia |
| Definition |
Prescription spectacle lenses to reduce the progression of myopia consist of spectacle lenses with additional physical optical design lens elements. In addition to optical correction of myopic refractive error, these lenses are intended to be used by children who have myopia to reduce the rate of myopia progression. The lenses are mounted within a spectacle frame classified under § 886.5842. |
| Physical State |
The Prescription spectacle lenses to reduce the progression of myopia in children are made of a transparent, impact resistant material mounted within a spectacle frame, as are prescription spectacle lenses. The spectacle lenses are mounted only into spectacle frames that are class I 510(k) exempt under 21 CFR 886.5842. The spectacle lenses do not have any tissue contact (direct or indirect) during wear. |
| Technical Method |
Prescription spectacle lenses to reduce the progression of myopia in children have an optical design that corrects refractive error and provides a stimulus, through the transmission of light from the surrounding environment, to slow the axial growth of the eye and to slow the progression of myopia over time. The prescription spectacle lens optical design is achieved based only on physical properties of the lenses. |
| Target Area |
The spectacle lens is mounted within a frame that positions the lenses directly in front of the eyes, without having physical contact with the eye surface or any other type of tissue contact during wear. Like the frames for other prescription spectacle lenses, the frames of this device sit on the nose with temples that extend behind the ears. The prescription spectacle lenses are mounted into frames that are class I 510(k) exempt under 21 CFR 886.5842. |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | QUR |
|---|
| Premarket Review |
Ophthalmic Devices
(DHT1A)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
886.5845
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
