Class Class II
Precision1, Precision1 for Astigmatism (K230785)
Description
Precision1, Precision1 for Astigmatism by Alcon Laboratories, Inc., an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230785
Clearance Date2023-04-20
Clearance TypeSpecial
Product CodeLPL
Regulation Number886.5925
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230785
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Precision1, Precision1 for Astigmatism (K230785) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182902 | Precision1 | Alcon Laboratories, Inc. | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 fo... | Alcon Laboratories, Inc. | 2023 |
Trace the full predicate network for K230785
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.