Submission Details
| 510(k) Number | K182247 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 20, 2018 |
| Decision Date | October 12, 2018 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
K182247 - ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
(FDA 510(k) Clearance)
Oct 2018
Decision
53d
Days
Class 2
Risk
K182247 is an FDA 510(k) clearance for the ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color), a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Vizionfocus, Inc. (Zhunan Township, TW). The FDA issued a Cleared decision on October 12, 2018, 53 days after receiving the submission on August 20, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.
Device Classification
| Product Code | LPL — Lenses, Soft Contact, Daily Wear |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5925 |
Similar Devices — LPL Lenses, Soft Contact, Daily Wear
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