HUMAN II LENS
Device Facts
| Record ID | K781927 |
|---|---|
| Device Name | HUMAN II LENS |
| Applicant | Spectra-Shield, Inc. |
| Product Code | HQG · Ophthalmic |
| Decision Date | Dec 20, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5844 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.
