Submission Details
| 510(k) Number | K042176 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 11, 2004 |
| Decision Date | November 03, 2004 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
AQUIFY LENS COMFORT DROPS
Nov 2004
Decision
84d
Days
Class 2
Risk
About This 510(k) Submission
K042176 is an FDA 510(k) clearance for the AQUIFY LENS COMFORT DROPS, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on November 3, 2004, 84 days after receiving the submission on August 11, 2004. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LPN — Accessories, Soft Lens Products |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
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