Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens (K242916)
Description
Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens by Largan Medical Co., Ltd., an FDA 510(k) cleared ophthalmic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242916
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. Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens (K242916) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182674 | Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contac... | Largan Medical Co., Ltd. | 2018 |
| K182523 | Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophil... | Largan Medical Co., Ltd. | 2018 |
Trace the full predicate network for K242916
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.