510(k) K853758
K853758 is an FDA 510(k) premarket notification submitted by Golden Dental Products, Inc. for the device "PY-RITE". The FDA issued a decision of Substantially Equivalent on December 3, 1985. The device falls under product code NJH (Lens, Spectacle (Prescription), For Reading Discomfort), a Class I device regulated under 21 CFR 886.5844.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1985
- Date Received
- September 9, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Spectacle (Prescription), For Reading Discomfort
- Device Class
- Class I
- Regulation Number
- 886.5844
- Review Panel
- OP
- Submission Type
Colored spectacle lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.